Non Small Cell Lung Cancer
Conditions
Brief summary
This study will compare the overall survival of participants with locally-advanced, Stage III Non-Small Cell Lung Cancer (NSCLC) with nonsquamous cell histology.
Interventions
DRUGPemetrexed
infusion over 10 minutes
DRUGCisplatin
infusion over 60 minutes with adequate anti-emetic treatment and appropriate hydration per local practice guidelines
DRUGEtoposide
administered per local practice guidelines over a minimum of 30 minutes
DRUGVinorelbine
administered over 6-10 minutes infusion per local practice guidelines
DRUGPaclitaxel
administered as a 3-hour infusion
DRUGCarboplatin
administered per local practice guidelines over 30 minutes
RADIATIONThoracic Radiation Therapy (TRT)
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participants must have Stage IIIA or IIIIB NSCLC of the non-squamous type * Participants must have measureable tumor lesions according to the Response Evaluation Criteria in Solid Tumors (RECIST) guidelines or disease that can be evaluated on computerized tomography (CT) scan * Participants must be physically mobile, take care of themselves and must be up and about and able to perform light activities, such as light housework or office work * Participants must be 18 years of age or older * Participants must have lost no more than 10% of their body weight in the previous 3 months * Women must be sterile, postmenopausal, or on contraception, and men must be sterile or on contraception * Participants' test results assessing the function of their blood forming tissue, kidneys, liver, and lungs must be satisfactory * Participants with Stage IIIB NSCLC who have supraclavicular nodal involvement may be entered into this study. However, participants with cervical nodes are not permitted. The upper border of supraclavicular nodes must not extend above the upper border of the lateral end of the clavicle, extended medially.
Exclusion criteria
* Participants cannot have other on-going (uncontrolled) illnesses, including active infections, recent heart problems, or psychiatric illnesses * Participants who are unable to take vitamins (including injections of vitamin B12) or oral cortisone medication * Participants who have had a heart attack (myocardial infarction) or other cardiac issues within 6 months of the trial * Participants who have received other investigational drugs within the last 30 days * Participants who are unable to stop taking more than 1.3 grams of aspirin on a daily basis or non-steroidal anti-inflammatory agents * Participants who have diseases considered for surgical treatment as part of their care plan, such as Pancoast or superior sulcus tumors * Participants who had prior thoracic radiation. However, other prior radiotherapy is allowed. Participants must have recovered from the toxic effects of the treatment prior to study enrollment. Participants may not have received whole pelvis radiation or radiation to more than 25% of their bone marrow. Prior radiotherapy must have been completed at least 30 days prior to study treatment. * Participants who have a radiation treatment plan that would expose more than 35% of the volume of their lung to 20 gray (Gy) or more of radiation * Participants who have concurrent cancer from another primary site requiring treatment of any kind within the past 5 years. Exemptions to this will be permitted on a case-by-case basis after prior approval by the Sponsor physician or designate if the investigator believes the participant's risk of recurrence and death is very low. Curatively treated nonmelanoma skin cancer or in situ carcinoma of any origin is allowed. Participants with recurrence of a previously resected lung cancer or who have a second primary lung cancer are ineligible.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival | Baseline to Date of Death from Any Cause (Up to 71.4 Months) | Overall survival (OS) time is from baseline to the date of death from any cause. For participants not known to have died as of the data cut-off date, OS time was censored at the last contact date the participant was known to be alive prior to the data cut-off date. OS was summarized using Kaplan-Meier estimates. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free Survival (PFS) | Baseline to Measured Progressive Disease or Death from Any Cause (Up to 66.6 Months) | Progression-free survival (PFS) time is from baseline to the first date of documented objective progressive disease (PD) or death from any cause. For participants who were not known to have died or to have had objective PD as of the data inclusion cut-off date for a particular analysis, PFS was censored at the date of the last objective progression-free disease assessments. For participants who took any subsequent systemic anticancer therapy prior to progression or death, PFS was censored at the date of the last objective progression-free disease assessment prior to the start date of any subsequent systemic anticancer therapy. PFS time was summarized using Kaplan-Meier estimates. |
| Objective Response Rate (Complete Response [CR] + Partial Response [PR]) | Baseline to Measured Progressive Disease (Up to 7 Months) | Overall response rate (ORR) is the best response of CR or PR as classified by the investigators according to the Response Evaluation Criteria in Solid Tumors (RECIST, v1.1) guidelines. CR is defined as the disappearance of all target and non-target lesions, normalization of tumor marker level of non-target lesions, and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 millimeter (mm). PR is an at least 30% decrease in the sum of the diameters of target lesions (taking as reference the baseline sum diameter) without progression of non-target lesions or appearance of new lesions. Overall response rate is calculated as a total number of participants with CR or PR divided by the total number of participants with at least 1 measurable lesion, multiplied by 100. |
| First Site of Disease Failure in Terms of Relapse | Baseline to Relapse (Up to 66.6 Months) | The percentage of participants with first sites of disease failure in terms of relapse within the radiation treatment field, inside the thorax, (outside of the radiation field), or distant disease are presented. Results were summarized using Kaplan-Meier estimates. Some participants relapsed in more than 1 location/site and appear in more than a single category. |
| Percentage of Participants With a Post Baseline Swallowing Diary Score >=4 | Baseline through 30 Days Post Study | Participants were provided with a swallowing diary to record issues with swallowing using a 5-point categorical scale: (1) no problems; (2) mild soreness; (3) swallowing solids with some difficulty; (4) inability to swallow solids; and (5) inability to swallow liquids. Participants rated swallowing over the previous 24 hours. The percentage of participants was calculated by dividing the number of with a post baseline swallowing diary score \>=4 by total number of participants analyzed, multiplied by 100. No adjustments were made for the number of available assessments nor were any interpolation of missing assessments made. |
| Survival Rates at 1, 2, and 3 Years | Baseline to Date of Death from Any Cause (Up to 71.4 Months) | The probability that survival time is at least 1, 2, or 3 years was summarized using Kaplan-Meier estimates. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events: The Number of Deaths Per Treatment Group | Baseline through 30 Days Post Study | The number of deaths that occurred while on study drug, the number of deaths due to adverse events (AEs) while on study drug, and the number of deaths due to the study disease (that is, disease progression) while on study drug are presented. In addition, the number of deaths within 30 days of treatment discontinuation, the number of deaths due to AEs within 30 days of treatment discontinuation, and the number of deaths due to study disease within 30 days of treatment discontinuation are presented. For both the deaths due to AEs that occurred on study and for deaths due to AEs that occurred within 30 days of treatment discontinuation, the causality (events assess as possibly related \[poss related\] to study drug per investigator judgement) is also presented. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module. |
Countries
Argentina, Australia, Belgium, Brazil, Canada, China, France, Germany, Greece, India, Ireland, Netherlands, Portugal, South Korea, Spain, Taiwan, Turkey (Türkiye), United Kingdom, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Arm A: Pemetrexed + Cisplatin and TRT Participants were treated with Pemetrexed plus Cisplatin and concurrent TRT (Concurrent Phase) for three 21-day cycles, followed by a 3-5 week Recovery Period, then treated with consolidation chemotherapy with pemetrexed (Consolidation Phase) for up to four 21-day cycles
Concurrent Phase:
Pemetrexed: 500 mg/m\^2, IV on Day 1 of each 21-day cycle for 3 cycles. Cisplatin: 75 mg/m\^2, IV on Day 1 of each 21-day cycle x 3 cycles. TRT: Beginning on Day 1 of chemotherapy, once daily fractions (2 Gy per day), 5 days a week for 6 weeks and 3 days to target 66 Gy in 33 fractions.
Consolidation Phase:
Pemetrexed: 500 mg/m\^2, IV on Day 1 of each 21-day cycle up to 4 cycles | 301 |
| Arm B: Etoposide + Cisplatin and TRT Participants were treated with Etoposide plus Cisplatin and concurrent TRT (Concurrent Phase) for two 28-day cycles, followed by a 3-5 week Recovery Period, then received consolidation treatment with cytotoxic chemotherapy of choice (Consolidation Phase) for up to 2 cycles
Concurrent Phase:
Etoposide/Cisplatin (28-day cycle); Etoposide: 50 mg/m\^2, IV on Days 1 to 5 and Days 29 to 33 and Cisplatin: 50 mg/m\^2, IV on Days1, 8, 29, and 36
Consolidation Phase options:
Option 1: Continue the same treatment plan as Concurrent Phase Option 2: Vinorelbine/Cisplatin (21-day cycle); Vinorelbine: 30 mg/m\^2, IV on Days 1, 8, 22, and 29; Cisplatin: 75 mg/m\^2, IV on Days 1 and 22 Option 3: Paclitaxel/Carboplatin (21-day cycle); Paclitaxel: 200 mg/m\^2, IV, on Days 1 and 22; Carboplatin: area under the concentration-time curve (AUC) = 6 (Carboplatin dosing based on calculated creatinine clearance), IV on Days 1 and 22 | 297 |
| Total | 598 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Participants censored (no death events) | 124 | 117 |
Baseline characteristics
| Characteristic | Arm B: Etoposide + Cisplatin and TRT | Arm A: Pemetrexed + Cisplatin and TRT | Total |
|---|---|---|---|
| Age, Continuous | 58.5 years STANDARD_DEVIATION 9.4 | 59.1 years STANDARD_DEVIATION 9.6 | 58.8 years STANDARD_DEVIATION 9.5 |
| Baseline PET scan No | 56 participants | 51 participants | 107 participants |
| Baseline PET scan Yes | 241 participants | 250 participants | 491 participants |
| Disease stage Missing | 3 participants | 0 participants | 3 participants |
| Disease stage Stage IIIA | 142 participants | 140 participants | 282 participants |
| Disease stage Stage IIIB | 152 participants | 161 participants | 313 participants |
| ECOG performance status 0 | 145 participants | 148 participants | 293 participants |
| ECOG performance status 1 | 149 participants | 152 participants | 301 participants |
| ECOG performance status Missing | 3 participants | 1 participants | 4 participants |
| Histology Adenocarcinoma | 226 participants | 226 participants | 452 participants |
| Histology Large cell carcinoma | 21 participants | 16 participants | 37 participants |
| Histology Missing | 2 participants | 0 participants | 2 participants |
| Histology Other | 48 participants | 59 participants | 107 participants |
| Race/Ethnicity, Customized African | 12 participants | 15 participants | 27 participants |
| Race/Ethnicity, Customized Caucasian | 204 participants | 217 participants | 421 participants |
| Race/Ethnicity, Customized East Asian | 68 participants | 54 participants | 122 participants |
| Race/Ethnicity, Customized Hispanic | 4 participants | 5 participants | 9 participants |
| Race/Ethnicity, Customized Missing (unknown) | 2 participants | 3 participants | 5 participants |
| Race/Ethnicity, Customized Native American | 1 participants | 1 participants | 2 participants |
| Race/Ethnicity, Customized West Asian | 6 participants | 6 participants | 12 participants |
| Region of Enrollment Argentina | 1 participants | 2 participants | 3 participants |
| Region of Enrollment Australia | 10 participants | 7 participants | 17 participants |
| Region of Enrollment Belgium | 23 participants | 21 participants | 44 participants |
| Region of Enrollment Brazil | 9 participants | 7 participants | 16 participants |
| Region of Enrollment Canada | 10 participants | 16 participants | 26 participants |
| Region of Enrollment China | 34 participants | 27 participants | 61 participants |
| Region of Enrollment France | 9 participants | 13 participants | 22 participants |
| Region of Enrollment Germany | 22 participants | 15 participants | 37 participants |
| Region of Enrollment Greece | 3 participants | 13 participants | 16 participants |
| Region of Enrollment India | 14 participants | 14 participants | 28 participants |
| Region of Enrollment Ireland | 0 participants | 1 participants | 1 participants |
| Region of Enrollment Korea, Republic of | 5 participants | 6 participants | 11 participants |
| Region of Enrollment Mexico | 0 participants | 2 participants | 2 participants |
| Region of Enrollment Netherlands | 20 participants | 26 participants | 46 participants |
| Region of Enrollment Portugal | 11 participants | 7 participants | 18 participants |
| Region of Enrollment Spain | 27 participants | 38 participants | 65 participants |
| Region of Enrollment Taiwan | 14 participants | 11 participants | 25 participants |
| Region of Enrollment Turkey | 4 participants | 3 participants | 7 participants |
| Region of Enrollment United Kingdom | 5 participants | 14 participants | 19 participants |
| Region of Enrollment United States | 76 participants | 58 participants | 134 participants |
| Sex: Female, Male Female | 119 Participants | 124 Participants | 243 Participants |
| Sex: Female, Male Male | 178 Participants | 177 Participants | 355 Participants |
| Smoking status Heavy smoker | 183 participants | 190 participants | 373 participants |
| Smoking status Missing | 18 participants | 19 participants | 37 participants |
| Smoking status Moderate smoker | 38 participants | 42 participants | 80 participants |
| Smoking status Never smoked | 58 participants | 50 participants | 108 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 279 / 283 | 269 / 272 |
| serious Total, serious adverse events | 134 / 283 | 145 / 272 |
Outcome results
Primary
Overall Survival
Overall survival (OS) time is from baseline to the date of death from any cause. For participants not known to have died as of the data cut-off date, OS time was censored at the last contact date the participant was known to be alive prior to the data cut-off date. OS was summarized using Kaplan-Meier estimates.
Time frame: Baseline to Date of Death from Any Cause (Up to 71.4 Months)
Population: All randomized participants. Arm A had 124 participants censored and Arm B had 117 participants censored.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Arm A: Pemetrexed + Cisplatin and TRT | Overall Survival | 26.81 months |
| Arm B: Etoposide + Cisplatin and TRT | Overall Survival | 24.97 months |
p-value: 0.83195% CI: [0.79, 1.2]Log Rank
Secondary
First Site of Disease Failure in Terms of Relapse
The percentage of participants with first sites of disease failure in terms of relapse within the radiation treatment field, inside the thorax, (outside of the radiation field), or distant disease are presented. Results were summarized using Kaplan-Meier estimates. Some participants relapsed in more than 1 location/site and appear in more than a single category.
Time frame: Baseline to Relapse (Up to 66.6 Months)
Population: All randomized participants with objective PD.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm A: Pemetrexed + Cisplatin and TRT | First Site of Disease Failure in Terms of Relapse | Relapsed within the radiation treatment field | 37.3 percentage of participants |
| Arm A: Pemetrexed + Cisplatin and TRT | First Site of Disease Failure in Terms of Relapse | Relapsed inside thorax, outside of radiation field | 20.5 percentage of participants |
| Arm A: Pemetrexed + Cisplatin and TRT | First Site of Disease Failure in Terms of Relapse | Relapsed distant disease | 50.0 percentage of participants |
| Arm B: Etoposide + Cisplatin and TRT | First Site of Disease Failure in Terms of Relapse | Relapsed within the radiation treatment field | 45.8 percentage of participants |
| Arm B: Etoposide + Cisplatin and TRT | First Site of Disease Failure in Terms of Relapse | Relapsed inside thorax, outside of radiation field | 16.3 percentage of participants |
| Arm B: Etoposide + Cisplatin and TRT | First Site of Disease Failure in Terms of Relapse | Relapsed distant disease | 45.8 percentage of participants |
Comparison: Relapsed within the radiation treatment fieldp-value: 0.132Fisher Exact
Comparison: Relapsed inside thorax, outside of radiation fieldp-value: 0.337Fisher Exact
Comparison: Relapsed distant diseasep-value: 0.457Fisher Exact
Secondary
Objective Response Rate (Complete Response [CR] + Partial Response [PR])
Overall response rate (ORR) is the best response of CR or PR as classified by the investigators according to the Response Evaluation Criteria in Solid Tumors (RECIST, v1.1) guidelines. CR is defined as the disappearance of all target and non-target lesions, normalization of tumor marker level of non-target lesions, and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 millimeter (mm). PR is an at least 30% decrease in the sum of the diameters of target lesions (taking as reference the baseline sum diameter) without progression of non-target lesions or appearance of new lesions. Overall response rate is calculated as a total number of participants with CR or PR divided by the total number of participants with at least 1 measurable lesion, multiplied by 100.
Time frame: Baseline to Measured Progressive Disease (Up to 7 Months)
Population: All randomized participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm A: Pemetrexed + Cisplatin and TRT | Objective Response Rate (Complete Response [CR] + Partial Response [PR]) | 35.9 percentage of participants |
| Arm B: Etoposide + Cisplatin and TRT | Objective Response Rate (Complete Response [CR] + Partial Response [PR]) | 33.0 percentage of participants |
p-value: 0.458Log Rank
Secondary
Percentage of Participants With a Post Baseline Swallowing Diary Score >=4
Participants were provided with a swallowing diary to record issues with swallowing using a 5-point categorical scale: (1) no problems; (2) mild soreness; (3) swallowing solids with some difficulty; (4) inability to swallow solids; and (5) inability to swallow liquids. Participants rated swallowing over the previous 24 hours. The percentage of participants was calculated by dividing the number of with a post baseline swallowing diary score \>=4 by total number of participants analyzed, multiplied by 100. No adjustments were made for the number of available assessments nor were any interpolation of missing assessments made.
Time frame: Baseline through 30 Days Post Study
Population: All randomized participants with at least one post baseline swallowing diary score.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm A: Pemetrexed + Cisplatin and TRT | Percentage of Participants With a Post Baseline Swallowing Diary Score >=4 | 33.8 percentage of participants |
| Arm B: Etoposide + Cisplatin and TRT | Percentage of Participants With a Post Baseline Swallowing Diary Score >=4 | 29.0 percentage of participants |
p-value: 0.15Fisher Exact
Secondary
Progression-free Survival (PFS)
Progression-free survival (PFS) time is from baseline to the first date of documented objective progressive disease (PD) or death from any cause. For participants who were not known to have died or to have had objective PD as of the data inclusion cut-off date for a particular analysis, PFS was censored at the date of the last objective progression-free disease assessments. For participants who took any subsequent systemic anticancer therapy prior to progression or death, PFS was censored at the date of the last objective progression-free disease assessment prior to the start date of any subsequent systemic anticancer therapy. PFS time was summarized using Kaplan-Meier estimates.
Time frame: Baseline to Measured Progressive Disease or Death from Any Cause (Up to 66.6 Months)
Population: All randomized participants. Arm A had 99 participants censored and Arm B had 87 participants censored.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Arm A: Pemetrexed + Cisplatin and TRT | Progression-free Survival (PFS) | 11.37 months |
| Arm B: Etoposide + Cisplatin and TRT | Progression-free Survival (PFS) | 9.76 months |
p-value: 0.1395% CI: [0.71, 1.04]Log Rank
Secondary
Survival Rates at 1, 2, and 3 Years
The probability that survival time is at least 1, 2, or 3 years was summarized using Kaplan-Meier estimates.
Time frame: Baseline to Date of Death from Any Cause (Up to 71.4 Months)
Population: All randomized participants. Arm A had 124 participants censored and Arm B had 117 participants censored.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm A: Pemetrexed + Cisplatin and TRT | Survival Rates at 1, 2, and 3 Years | 1 year (12 months) | 0.76 probability of survival |
| Arm A: Pemetrexed + Cisplatin and TRT | Survival Rates at 1, 2, and 3 Years | 2 years (24 months) | 0.52 probability of survival |
| Arm A: Pemetrexed + Cisplatin and TRT | Survival Rates at 1, 2, and 3 Years | 3 years (36 months) | 0.40 probability of survival |
| Arm B: Etoposide + Cisplatin and TRT | Survival Rates at 1, 2, and 3 Years | 3 years (36 months) | 0.37 probability of survival |
| Arm B: Etoposide + Cisplatin and TRT | Survival Rates at 1, 2, and 3 Years | 1 year (12 months) | 0.77 probability of survival |
| Arm B: Etoposide + Cisplatin and TRT | Survival Rates at 1, 2, and 3 Years | 2 years (24 months) | 0.52 probability of survival |
Other Pre-specified
Adverse Events: The Number of Deaths Per Treatment Group
The number of deaths that occurred while on study drug, the number of deaths due to adverse events (AEs) while on study drug, and the number of deaths due to the study disease (that is, disease progression) while on study drug are presented. In addition, the number of deaths within 30 days of treatment discontinuation, the number of deaths due to AEs within 30 days of treatment discontinuation, and the number of deaths due to study disease within 30 days of treatment discontinuation are presented. For both the deaths due to AEs that occurred on study and for deaths due to AEs that occurred within 30 days of treatment discontinuation, the causality (events assess as possibly related \[poss related\] to study drug per investigator judgement) is also presented. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
Time frame: Baseline through 30 Days Post Study
Population: All randomized participants who received at least one dose of study drug.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm A: Pemetrexed + Cisplatin and TRT | Adverse Events: The Number of Deaths Per Treatment Group | On study drug (total) | 12 participants |
| Arm A: Pemetrexed + Cisplatin and TRT | Adverse Events: The Number of Deaths Per Treatment Group | On study drug: Due to AE | 10 participants |
| Arm A: Pemetrexed + Cisplatin and TRT | Adverse Events: The Number of Deaths Per Treatment Group | On study drug: Due to AE poss related | 5 participants |
| Arm A: Pemetrexed + Cisplatin and TRT | Adverse Events: The Number of Deaths Per Treatment Group | On study drug: Due to study disease | 2 participants |
| Arm A: Pemetrexed + Cisplatin and TRT | Adverse Events: The Number of Deaths Per Treatment Group | Within 30 Days of Discontinuation (disc) (total) | 10 participants |
| Arm A: Pemetrexed + Cisplatin and TRT | Adverse Events: The Number of Deaths Per Treatment Group | Within 30 Days of Disc: Due to AE | 5 participants |
| Arm A: Pemetrexed + Cisplatin and TRT | Adverse Events: The Number of Deaths Per Treatment Group | Within 30 Days of Disc: Due to AE poss related | 2 participants |
| Arm A: Pemetrexed + Cisplatin and TRT | Adverse Events: The Number of Deaths Per Treatment Group | Within 30 Days of Disc: Due to study disease | 5 participants |
| Arm B: Etoposide + Cisplatin and TRT | Adverse Events: The Number of Deaths Per Treatment Group | Within 30 Days of Disc: Due to study disease | 2 participants |
| Arm B: Etoposide + Cisplatin and TRT | Adverse Events: The Number of Deaths Per Treatment Group | On study drug (total) | 6 participants |
| Arm B: Etoposide + Cisplatin and TRT | Adverse Events: The Number of Deaths Per Treatment Group | Within 30 Days of Discontinuation (disc) (total) | 6 participants |
| Arm B: Etoposide + Cisplatin and TRT | Adverse Events: The Number of Deaths Per Treatment Group | On study drug: Due to AE | 4 participants |
| Arm B: Etoposide + Cisplatin and TRT | Adverse Events: The Number of Deaths Per Treatment Group | Within 30 Days of Disc: Due to AE poss related | 0 participants |
| Arm B: Etoposide + Cisplatin and TRT | Adverse Events: The Number of Deaths Per Treatment Group | On study drug: Due to AE poss related | 3 participants |
| Arm B: Etoposide + Cisplatin and TRT | Adverse Events: The Number of Deaths Per Treatment Group | Within 30 Days of Disc: Due to AE | 4 participants |
| Arm B: Etoposide + Cisplatin and TRT | Adverse Events: The Number of Deaths Per Treatment Group | On study drug: Due to study disease | 0 participants |