Lung Neoplasms
Conditions
Brief summary
The purpose of this study is to help answer: * Whether pemetrexed, gemcitabine and/or carboplatin can shrink tumor(s) or make tumor(s) disappear in patients with relapsed lung cancer (lung cancer that has come back after surgical removal and chemotherapy), and to determine how long this will last * Whether pemetrexed, gemcitabine and/or carboplatin can help patients with relapsed lung cancer live longer
Interventions
DRUGpemetrexed
500 mg/m2, intravenous (IV), every 14 days x 6 cycles or until disease progression
DRUGgemcitabine
1500 mg/m2, intravenous (IV), every 14 days x 6 cycles or until disease progression
DRUGcarboplatin
area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles or until disease progression
DRUGPemetrexed
500 mg/m2, intravenous (IV), every 21 days x 6 cycles or until disease progression
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
* You have non-small cell lung cancer that has come back (relapsed) after initial treatment with surgery and chemotherapy. * You have good kidney, liver, and bone marrow organ function. * You are fully active or able to carry out light work such as housework or office work.
Exclusion criteria
* You have received pemetrexed or gemcitabine in the past for lung cancer * You are currently receiving another treatment for your relapsed lung cancer, or have had chemotherapy or certain other therapies for relapsed lung cancer in the past * You are unable to take corticosteroid drugs like dexamethasone * You are unable or unwilling to take the folic acid pills or Vitamin B12 injections that are required for the study * You are unable to stop taking aspirin or other drugs that control inflammation for certain periods of time during the study * You have had a heart attack in the last 6 months, or have other heart problems that are not controlled with medication
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective Tumor Response | baseline to time of response (up to 17.5 months) | Best response recorded from the start of treatment until disease progression/recurrence using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival | baseline to trial termination (17.5 months) | Overall survival is the number of participants who were alive when the trial was terminated. |
| Time to Progressive Disease | baseline to measured progressive disease (up to 17.5 months) | — |
| Duration of Response | time of response to progressive disease (up to 17.5 months) | — |
| Time to Treatment Failure | baseline to stopping treatment (up to 17.5 months) | — |
Countries
Brazil, India, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Less Than One Year: Pemetrexed Disease relapse at less than one year after neoadjuvant/adjuvant chemotherapy. Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles or until disease progression | 14 |
| Less Than One Year: Pemetrexed + Gemcitabine Disease relapse at less than one year after neoadjuvant/adjuvant chemotherapy. Pemetrexed: 500 mg/m2, intravenous (IV), every 14 days x 6 cycles or until disease progression Gemcitabine: 1500 mg/m2, IV, every 14 days x 6 cycles or until disease progression | 11 |
| One Year or Greater: Pemetrexed + Carboplatin Disease relapse at one year or greater after neoadjuvant/adjuvant chemotherapy. Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles or until disease progression Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles or until disease progression | 7 |
| One Year or Greater: Pemetrexed + Gemcitabine Disease relapse at one year or greater after neoadjuvant/adjuvant chemotherapy. Pemetrexed: 500 mg/m2, intravenous (IV), every 14 days x 6 cycles or until disease progression Gemcitabine: 1500 mg/m2, IV, every 14 days x 6 cycles or until disease progression | 9 |
| Total | 41 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 3 | 1 | 1 |
| Overall Study | Death | 0 | 0 | 0 | 1 |
| Overall Study | Lost to Follow-up | 1 | 0 | 0 | 0 |
| Overall Study | Physician Decision | 2 | 2 | 2 | 1 |
| Overall Study | Progressive Disease | 8 | 5 | 4 | 2 |
| Overall Study | Protocol Entry Criteria Not Met | 1 | 0 | 0 | 0 |
| Overall Study | Sponsor Decision | 0 | 0 | 0 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 1 | 0 | 3 |
Baseline characteristics
| Characteristic | Total | Less Than One Year: Pemetrexed | Less Than One Year: Pemetrexed + Gemcitabine | One Year or Greater: Pemetrexed + Carboplatin | One Year or Greater: Pemetrexed + Gemcitabine |
|---|---|---|---|---|---|
| Age, Customized <=65 years | 15 participants | 6 participants | 3 participants | 2 participants | 4 participants |
| Age, Customized >65 years | 26 participants | 8 participants | 8 participants | 5 participants | 5 participants |
| Disease Stage at Initial Diagnosis Stage IV | 41 participants | 14 participants | 11 participants | 7 participants | 9 participants |
| Eastern Cooperative Oncology Group Performance Status 0 - Fully Active | 17 participants | 6 participants | 3 participants | 2 participants | 6 participants |
| Eastern Cooperative Oncology Group Performance Status 1 - Ambulatory, Restricted Strenuous Activity | 24 participants | 8 participants | 8 participants | 5 participants | 3 participants |
| History of Brain Metastates No | 39 participants | 12 participants | 11 participants | 7 participants | 9 participants |
| History of Brain Metastates Yes | 2 participants | 2 participants | 0 participants | 0 participants | 0 participants |
| Prior Systemic Therapy Adjuvant | 38 participants | 12 participants | 11 participants | 6 participants | 9 participants |
| Prior Systemic Therapy Neoadjuvant | 5 participants | 3 participants | 0 participants | 1 participants | 1 participants |
| Race/Ethnicity Black or African American | 2 participants | 0 participants | 0 participants | 2 participants | 0 participants |
| Race/Ethnicity Caucasian | 37 participants | 14 participants | 11 participants | 5 participants | 7 participants |
| Race/Ethnicity East Asian | 1 participants | 0 participants | 0 participants | 0 participants | 1 participants |
| Race/Ethnicity West Asian | 1 participants | 0 participants | 0 participants | 0 participants | 1 participants |
| Region of Enrollment United States | 41 participants | 14 participants | 11 participants | 7 participants | 9 participants |
| Sex: Female, Male Female | 16 Participants | 6 Participants | 6 Participants | 0 Participants | 4 Participants |
| Sex: Female, Male Male | 25 Participants | 8 Participants | 5 Participants | 7 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 14 / 14 | 11 / 11 | 7 / 7 | 9 / 9 |
| serious Total, serious adverse events | 3 / 14 | 5 / 11 | 0 / 7 | 2 / 9 |
Outcome results
Primary
Objective Tumor Response
Best response recorded from the start of treatment until disease progression/recurrence using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria.
Time frame: baseline to time of response (up to 17.5 months)
Population: Number of randomized participants in each category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Less Than One Year: Pemetrexed | Objective Tumor Response | Stable Disease | 3 participants |
| Less Than One Year: Pemetrexed | Objective Tumor Response | Complete Response | 0 participants |
| Less Than One Year: Pemetrexed | Objective Tumor Response | Progressive Disease | 2 participants |
| Less Than One Year: Pemetrexed | Objective Tumor Response | Partial Response | 7 participants |
| Less Than One Year: Pemetrexed | Objective Tumor Response | Unknown | 2 participants |
| Less Than One Year: Pemetrexed + Gemcitabine | Objective Tumor Response | Stable Disease | 9 participants |
| Less Than One Year: Pemetrexed + Gemcitabine | Objective Tumor Response | Partial Response | 0 participants |
| Less Than One Year: Pemetrexed + Gemcitabine | Objective Tumor Response | Progressive Disease | 2 participants |
| Less Than One Year: Pemetrexed + Gemcitabine | Objective Tumor Response | Complete Response | 0 participants |
| Less Than One Year: Pemetrexed + Gemcitabine | Objective Tumor Response | Unknown | 0 participants |
| One Year or Greater: Pemetrexed + Carboplatin | Objective Tumor Response | Unknown | 0 participants |
| One Year or Greater: Pemetrexed + Carboplatin | Objective Tumor Response | Complete Response | 0 participants |
| One Year or Greater: Pemetrexed + Carboplatin | Objective Tumor Response | Partial Response | 2 participants |
| One Year or Greater: Pemetrexed + Carboplatin | Objective Tumor Response | Stable Disease | 5 participants |
| One Year or Greater: Pemetrexed + Carboplatin | Objective Tumor Response | Progressive Disease | 0 participants |
| One Year or Greater: Pemetrexed + Gemcitabine | Objective Tumor Response | Unknown | 1 participants |
| One Year or Greater: Pemetrexed + Gemcitabine | Objective Tumor Response | Progressive Disease | 1 participants |
| One Year or Greater: Pemetrexed + Gemcitabine | Objective Tumor Response | Partial Response | 1 participants |
| One Year or Greater: Pemetrexed + Gemcitabine | Objective Tumor Response | Complete Response | 0 participants |
| One Year or Greater: Pemetrexed + Gemcitabine | Objective Tumor Response | Stable Disease | 6 participants |
Secondary
Duration of Response
Time frame: time of response to progressive disease (up to 17.5 months)
Population: Outcome measure was not analyzed due to insufficient data.
Secondary
Overall Survival
Overall survival is the number of participants who were alive when the trial was terminated.
Time frame: baseline to trial termination (17.5 months)
Population: Number of randomized participants in each category.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Less Than One Year: Pemetrexed | Overall Survival | 6 participants alive |
| Less Than One Year: Pemetrexed + Gemcitabine | Overall Survival | 4 participants alive |
| One Year or Greater: Pemetrexed + Carboplatin | Overall Survival | 6 participants alive |
| One Year or Greater: Pemetrexed + Gemcitabine | Overall Survival | 7 participants alive |
Secondary
Time to Progressive Disease
Time frame: baseline to measured progressive disease (up to 17.5 months)
Population: Outcome measure was not analyzed due to insufficient data.
Secondary
Time to Treatment Failure
Time frame: baseline to stopping treatment (up to 17.5 months)
Population: Outcome measure was not analyzed due to insufficient data.