Non-small Cell Lung Cancer
Conditions
Brief summary
To assess the 2 year survival of patients with Stage III unresectable non-small cell lung cancer receiving consolidation gemcitabine or gemcitabine plus docetaxel following concurrent chemotherapy and radiation.
Interventions
DRUGgemcitabine
After induction chemotherapy, radiation therapy and 10 weeks with no disease progression, randomized consolidation treatment begins. In both treatment arms, gemcitabine 1000 milligrams per meter squared (mg/m2), is administered intravenously (IV), on days 1 and 8 of every 21-day cycle for 3 cycles.
DRUGdocetaxel
Following cisplatin-etoposide induction chemotherapy, radiation therapy and 10 weeks with no disease progression, randomized consolidation treatment begins. In this treatment arm, docetaxel 75 mg/m2, is administered IV on day 1 of each 21-day cycle for 3 cycles. Docetaxel is given after gemcitabine.
DRUGcisplatin
As part of induction chemotherapy, cisplatin is given 50 mg/m2, IV, day 1, 8, 29 and 36 (spans 2 cycles)
DRUGetoposide
As part of induction chemotherapy, etoposide is given 50 mg/m2, IV, days 1-5 and 29-33 (spans 2 cycles)
RADIATIONradiation therapy
In conjunction with induction chemotherapy, radiation therapy is administered at a dose of 200 centi Gray (cGy) per day, Monday through Friday for 6 weeks
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
* histologic or cytologic proof of single primary non-small cell lung cancer * No prior chemotherapy or radiation therapy * no prior malignancy
Exclusion criteria
* pregnancy or breastfeeding * serious concomitant systemic disorder * unintentional weight loss greater than 10%
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 2-Year Survival | 2 years | Percentage of participants alive at 2 years. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With Overall Tumor Response | randomization and every 3 months up to 2 years of post-study followup | Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria: Complete Response (CR)=disappearance of all target lesions; Partial Response (PR) =30% decrease in sum of longest diameter of target lesions; Progressive Disease (PD) =20% increase in sum of longest diameter of target lesions; Stable Disease (SD)=small changes that do not meet above criteria. The total number of CRs plus PRs equals overall response rate (ORR). |
| Progression-Free Survival | baseline to measured progressive disease up to 2057 days | Defined as the time from randomization into consolidation treatment to the first date of documented disease progression or death. Progression-free survival time was censored at the date of the last follow-up visit at which disease was assessed for patients who were still alive and who had not progressed. |
| Overall Survival | baseline to date of death from any cause up to 2057 days | Overall survival is the duration from enrollment to death from any cause. For patients who are alive, overall survival is censored at the last contact. |
| Lung Cancer Symptom Scale (LCSS) Assessment Post-randomization | baseline to 3 months after last dose of study treatment (three 21-day cycles) | LCSS measures physical & functional dimensions. The patient scale contains 9 items, 3 summation & 6 symptom items. Each item is marked on a visual analog scale (0=low; 100=high). The mean of the 6 symptoms is used to calculate the average symptom burden index (ASBI). Improved=mean ASBI assessments from any 2 consecutive improved post-randomization assessments was at least 0.5 standard deviation (SD) below pre-randomization ASBI; worse=mean ASBI from any 2 consecutive post-randomization assessments was at least 0.5 SD above pre-randomization ASBI; stable=criteria for improved/worse not met. |
Countries
Argentina, China, South Korea, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Gemcitabine Consolidation Treatment: gemcitabine 1000 milligrams per meter squared (mg/m2), is administered intravenously (IV), on days 1 and 8 of every 21-day cycle for 3 cycles | 32 |
| Gemcitabine Plus Docetaxel Consolidation Treatment: gemcitabine 1000 milligrams per meter squared (mg/m2), is administered intravenously (IV), on days 1 and 8 of every 21-day cycle for 3 cycles; docetaxel 75 mg/m2, is administered IV on day 1 of each 21-day cycle for 3 cycles. Docetaxel is given after gemcitabine. | 32 |
| Total | 64 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 2 | 6 |
| Overall Study | Death | 2 | 0 |
| Overall Study | Disease Progression | 0 | 1 |
| Overall Study | Other | 1 | 2 |
| Overall Study | Withdrawal by Subject | 0 | 3 |
Baseline characteristics
| Characteristic | Total | Gemcitabine | Gemcitabine Plus Docetaxel |
|---|---|---|---|
| Age Continuous | 59.5 years STANDARD_DEVIATION 8.48 | 59.5 years STANDARD_DEVIATION 7.31 | 59.5 years STANDARD_DEVIATION 9.61 |
| Eastern Oncology Cooperative Group (ECOG) Performance Status 0 - Fully Active | 26 units on a scale | 12 units on a scale | 14 units on a scale |
| Eastern Oncology Cooperative Group (ECOG) Performance Status 1 - Ambulatory, Restricted Strenuous Activity | 37 units on a scale | 19 units on a scale | 18 units on a scale |
| Eastern Oncology Cooperative Group (ECOG) Performance Status 2 - Ambulatory, No Work Activities | 1 units on a scale | 1 units on a scale | 0 units on a scale |
| Race/Ethnicity, Customized Asian | 23 participants | 13 participants | 10 participants |
| Race/Ethnicity, Customized Black | 3 participants | 1 participants | 2 participants |
| Race/Ethnicity, Customized Caucasian | 37 participants | 18 participants | 19 participants |
| Race/Ethnicity, Customized Hispanic | 1 participants | 0 participants | 1 participants |
| Region of Enrollment Argentina | 3 participants | 1 participants | 2 participants |
| Region of Enrollment China | 17 participants | 10 participants | 7 participants |
| Region of Enrollment Korea, Republic of | 6 participants | 3 participants | 3 participants |
| Region of Enrollment United States | 38 participants | 18 participants | 20 participants |
| Sex: Female, Male Female | 11 Participants | 5 Participants | 6 Participants |
| Sex: Female, Male Male | 53 Participants | 27 Participants | 26 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 32 / 32 | 32 / 32 |
| serious Total, serious adverse events | 13 / 32 | 18 / 32 |
Outcome results
Primary
2-Year Survival
Percentage of participants alive at 2 years.
Time frame: 2 years
Population: Intention to treat (ITT) population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Gemcitabine | 2-Year Survival | 40.6 percentage of participants |
| Gemcitabine Plus Docetaxel | 2-Year Survival | 55.7 percentage of participants |
95% CI: [23.8, 56.8]normal approximation
95% CI: [36.8, 70.9]normal approximation
Secondary
Lung Cancer Symptom Scale (LCSS) Assessment Post-randomization
LCSS measures physical & functional dimensions. The patient scale contains 9 items, 3 summation & 6 symptom items. Each item is marked on a visual analog scale (0=low; 100=high). The mean of the 6 symptoms is used to calculate the average symptom burden index (ASBI). Improved=mean ASBI assessments from any 2 consecutive improved post-randomization assessments was at least 0.5 standard deviation (SD) below pre-randomization ASBI; worse=mean ASBI from any 2 consecutive post-randomization assessments was at least 0.5 SD above pre-randomization ASBI; stable=criteria for improved/worse not met.
Time frame: baseline to 3 months after last dose of study treatment (three 21-day cycles)
Population: as-treated population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gemcitabine | Lung Cancer Symptom Scale (LCSS) Assessment Post-randomization | Improvement | 8 participants |
| Gemcitabine | Lung Cancer Symptom Scale (LCSS) Assessment Post-randomization | Stable | 10 participants |
| Gemcitabine | Lung Cancer Symptom Scale (LCSS) Assessment Post-randomization | Worse | 2 participants |
| Gemcitabine Plus Docetaxel | Lung Cancer Symptom Scale (LCSS) Assessment Post-randomization | Improvement | 5 participants |
| Gemcitabine Plus Docetaxel | Lung Cancer Symptom Scale (LCSS) Assessment Post-randomization | Stable | 9 participants |
| Gemcitabine Plus Docetaxel | Lung Cancer Symptom Scale (LCSS) Assessment Post-randomization | Worse | 8 participants |
Secondary
Number of Patients With Overall Tumor Response
Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria: Complete Response (CR)=disappearance of all target lesions; Partial Response (PR) =30% decrease in sum of longest diameter of target lesions; Progressive Disease (PD) =20% increase in sum of longest diameter of target lesions; Stable Disease (SD)=small changes that do not meet above criteria. The total number of CRs plus PRs equals overall response rate (ORR).
Time frame: randomization and every 3 months up to 2 years of post-study followup
Population: ITT population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Gemcitabine | Number of Patients With Overall Tumor Response | 24 participants |
| Gemcitabine Plus Docetaxel | Number of Patients With Overall Tumor Response | 27 participants |
95% CI: [56.6, 88.5]normal approximation
95% CI: [67.2, 94.7]Normal approximation
Secondary
Overall Survival
Overall survival is the duration from enrollment to death from any cause. For patients who are alive, overall survival is censored at the last contact.
Time frame: baseline to date of death from any cause up to 2057 days
Population: ITT population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Gemcitabine | Overall Survival | 492.5 days |
| Gemcitabine Plus Docetaxel | Overall Survival | 899.0 days |
p-value: 0.38Log Rank
Secondary
Progression-Free Survival
Defined as the time from randomization into consolidation treatment to the first date of documented disease progression or death. Progression-free survival time was censored at the date of the last follow-up visit at which disease was assessed for patients who were still alive and who had not progressed.
Time frame: baseline to measured progressive disease up to 2057 days
Population: ITT population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Gemcitabine | Progression-Free Survival | 162.5 days |
| Gemcitabine Plus Docetaxel | Progression-Free Survival | 408.0 days |
p-value: 0.08Log Rank