Not provided
Not provided
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Study halted prematurely and will not resume; participants are no longer being examined or receiving intervention.
Not provided
Not provided
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| Name | Class |
|---|---|
| Bristol-Myers Squibb | INDUSTRY |
Not provided
Not provided
Not provided
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The purpose of this study was to evaluate the efficacy and safety of the combination of nivolumab plus epacadostat in combination with platinum chemotherapy compared with platinum chemotherapy alone, in participants with treatment-naïve Stage 4 or recurrent non-small cell lung cancer (NSCLC).
Not provided
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A | Experimental | Nivolumab plus epacadostat in combination with platinum doublet |
|
| Arm B | Active Comparator | Platinum doublet chemotherapy |
|
| Arm C | Experimental | Nivolumab plus placebo in combination with platinum doublet chemotherapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nivolumab | Drug | Nivolumab administered intravenously at the protocol-defined dose every 3 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) of Nivolumab Plus Epacadostat in Combination With Chemotherapy (Arm A) Compared to Chemotherapy (Arm B) | Defined as the time from randomization to the date of death from any cause. | Approximately 38 months |
| Progression-free Survival (PFS) of Nivolumab Plus Epacadostat in Combination With Chemotherapy (Arm A) Compared to Chemotherapy (Arm B) | Defined as the time between the date of randomization and the first date of documented progression assessed by blinded independent central review, or death due to any cause, whichever occurs first. | Approximately 25 months |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) of Nivolumab Plus Epacadostat in Combination With Chemotherapy (Arm A) Compared to Chemotherapy (Arm B) | Defined as the proportion of participants who achieve a confirmed best response of complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) criteria as assessed by blinded independent central review. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Sridhar K. Rabindran, PhD | Bristol-Myers Squibb Research and Development | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pacific Cancer Medical Center, Inc | Anaheim | California | 92801 | United States | ||
| Cancer Center of Kansas |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Approximately 630 participants were planned to be randomized. Prior to the termination of the study, 2 participants were randomized to the Platinum Doublet Chemotherapy arm (Arm B) and treated.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Nivolumab + Epacadostat/Platinum Doublet Chemotherapy | Nivolumab + Epacadostat/Platinum Doublet Chemotherapy included the following: Nivolumab was administered intravenously at the protocol-defined dose every 3 weeks. Epacadostat was administered orally at the protocol-defined dose twice daily. Carboplatin was administered intravenously at the protocol-defined dose every 3 weeks for up to 4 cycles. Cisplatin was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Gemcitabine was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Paclitaxel was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Pemetrexed was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Optional continuation maintenance was available every 3 weeks, if eligible. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 23, 2017 | Jun 12, 2019 |
Not provided
Not provided
Not provided
Not provided
Not provided
| Epacadostat | Drug | Epacadostat administered orally at the protocol-defined dose twice daily. |
|
|
| Placebo | Drug | Matching placebo for epacadostat administered orally twice daily. |
|
| Carboplatin | Drug | Carboplatin administered intravenously at the protocol-defined dose every 3 weeks for up to 4 cycles. |
|
| Cisplatin | Drug | Cisplatin administered intravenously at the protocol-defined dose every 3 weeks for up to 4 cycles. |
|
| Gemcitabine | Drug | Gemcitabine administered intravenously at the protocol-defined dose every 3 weeks for up to 4 cycles. |
|
| Paclitaxel | Drug | Paclitaxel administered intravenously at the protocol-defined dose every 3 weeks for up to 4 cycles. |
|
| Pemetrexed | Drug | Pemetrexed administered intravenously at the protocol-defined dose every 3 weeks for up to 4 cycles. Optional continuation maintenance every 3 weeks, if eligible. |
|
| Approximately 25 months |
| Duration of Response (DOR) of Nivolumab Plus Epacadostat in Combination With Chemotherapy (Arm A) Compared to Chemotherapy (Arm B) | Defined as the time between the date of first confirmed response and the date of the first documented tumor progression (per RECIST v1.1) assessed by blinded independent central review or death due to any cause, whichever occurs first. | Approximately 25 months |
| Estimate of OS of Nivolumab and Placebo in Combination With Chemotherapy (Arm C) | Defined as the time from randomization to the date of death from any cause. | Approximately 38 months |
| Estimate of PFS of Nivolumab and Placebo in Combination With Chemotherapy (Arm C) | Defined as the time between the date of randomization and the first date of documented progression assessed by blinded independent central review or death due to any cause, whichever occurs first. | Approximately 25 months |
| Estimate of ORR of Nivolumab and Placebo in Combination With Chemotherapy (Arm C) | Defined as the proportion of participants who achieve a confirmed best response of CR or PR per RECIST v1.1 criteria as assessed by blinded independent central review. | Approximately 25 months |
| Estimate of DOR of Nivolumab and Placebo in Combination With Chemotherapy (Arm C) | Defined as the time between the date of first confirmed response and the date of the first documented tumor progression (per RECIST v1.1) assessed by blinded independent central review or death due to any cause, whichever occurs first. | Approximately 25 months |
| Wichita |
| Kansas |
| 67214 |
| United States |
| FG001 | Platinum Doublet Chemotherapy | Platinum Doublet Chemotherapy included the following: Carboplatin was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Cisplatin was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Gemcitabine was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Paclitaxel was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Pemetrexed was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Optional continuation maintenance was available every 3 weeks, if eligible. |
| FG002 | Nivolumab + Placebo Combination/Platinum Doublet Chemotherapy | Nivolumab plus placebo in combination with platinum doublet chemotherapy included: Nivolumab was administered intravenously at the protocol-defined dose every 3 weeks. : Matching placebo for epacadostat was administered orally twice daily. Carboplatin was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Cisplatin was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Gemcitabine was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Paclitaxel was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Pemetrexed was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Optional continuation maintenance was available every 3 weeks, if eligible. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
All randomized participants.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Nivolumab + Epacadostat/Platinum Doublet Chemotherapy | Nivolumab + Epacadostat/Platinum Doublet Chemotherapy included the following: Nivolumab was administered intravenously at the protocol-defined dose every 3 weeks. Epacadostat was administered orally at the protocol-defined dose twice daily. Carboplatin was administered intravenously at the protocol-defined dose every 3 weeks for up to 4 cycles. Cisplatin was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Gemcitabine was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Paclitaxel was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Pemetrexed was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Optional continuation maintenance was available every 3 weeks, if eligible. |
| BG001 | Platinum Doublet Chemotherapy | Platinum Doublet Chemotherapy included the following: Carboplatin was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Cisplatin was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Gemcitabine was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Paclitaxel was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Pemetrexed was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Optional continuation maintenance was available every 3 weeks, if eligible. |
| BG002 | Nivolumab + Placebo Combination/Platinum Doublet Chemotherapy | Nivolumab plus placebo in combination with platinum doublet chemotherapy included: Nivolumab was administered intravenously at the protocol-defined dose every 3 weeks. : Matching placebo for epacadostat was administered orally twice daily. Carboplatin was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Cisplatin was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Gemcitabine was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Paclitaxel was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Pemetrexed was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Optional continuation maintenance was available every 3 weeks, if eligible. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Overall Survival (OS) of Nivolumab Plus Epacadostat in Combination With Chemotherapy (Arm A) Compared to Chemotherapy (Arm B) | Defined as the time from randomization to the date of death from any cause. | All randomized participants; Arm A did not enroll any participants in the study and as a result no comparisons were performed and since the study was terminated early no efficacy analyses were conducted. | Posted | Approximately 38 months |
|
| ||||||||||||||||||||||
| Primary | Progression-free Survival (PFS) of Nivolumab Plus Epacadostat in Combination With Chemotherapy (Arm A) Compared to Chemotherapy (Arm B) | Defined as the time between the date of randomization and the first date of documented progression assessed by blinded independent central review, or death due to any cause, whichever occurs first. | All randomized participants; Arm A did not enroll any participants in the study and as a result no comparisons were performed and since the study was terminated early no efficacy analyses were conducted. | Posted | Approximately 25 months |
| |||||||||||||||||||||||
| Secondary | Objective Response Rate (ORR) of Nivolumab Plus Epacadostat in Combination With Chemotherapy (Arm A) Compared to Chemotherapy (Arm B) | Defined as the proportion of participants who achieve a confirmed best response of complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) criteria as assessed by blinded independent central review. | All randomized participants; Arm A did not enroll any participants in the study and as a result no comparisons were performed and since the study was terminated early no efficacy analyses were conducted. | Posted | Approximately 25 months |
| |||||||||||||||||||||||
| Secondary | Duration of Response (DOR) of Nivolumab Plus Epacadostat in Combination With Chemotherapy (Arm A) Compared to Chemotherapy (Arm B) | Defined as the time between the date of first confirmed response and the date of the first documented tumor progression (per RECIST v1.1) assessed by blinded independent central review or death due to any cause, whichever occurs first. | All randomized participants; Arm A did not enroll any participants in the study and as a result no comparisons were performed and since the study was terminated early no efficacy analyses were conducted. | Posted | Approximately 25 months |
| |||||||||||||||||||||||
| Secondary | Estimate of OS of Nivolumab and Placebo in Combination With Chemotherapy (Arm C) | Defined as the time from randomization to the date of death from any cause. | All randomized participants; Arm C did not enroll any participants in the study and as a result no analyses were performed and since the study was terminated early no efficacy analyses were conducted. | Posted | Approximately 38 months |
|
| ||||||||||||||||||||||
| Secondary | Estimate of PFS of Nivolumab and Placebo in Combination With Chemotherapy (Arm C) | Defined as the time between the date of randomization and the first date of documented progression assessed by blinded independent central review or death due to any cause, whichever occurs first. | All randomized participants; Arm C did not enroll any participants in the study and as a result no analyses were performed and since the study was terminated early no efficacy analyses were conducted. | Posted | Approximately 25 months |
|
| ||||||||||||||||||||||
| Secondary | Estimate of ORR of Nivolumab and Placebo in Combination With Chemotherapy (Arm C) | Defined as the proportion of participants who achieve a confirmed best response of CR or PR per RECIST v1.1 criteria as assessed by blinded independent central review. | All randomized participants; Arm C did not enroll any participants in the study and as a result no analyses were performed and since the study was terminated early no efficacy analyses were conducted. | Posted | Approximately 25 months |
|
| ||||||||||||||||||||||
| Secondary | Estimate of DOR of Nivolumab and Placebo in Combination With Chemotherapy (Arm C) | Defined as the time between the date of first confirmed response and the date of the first documented tumor progression (per RECIST v1.1) assessed by blinded independent central review or death due to any cause, whichever occurs first. | All randomized participants; Arm C did not enroll any participants in the study and as a result no analyses were performed and since the study was terminated early no efficacy analyses were conducted. | Posted | Approximately 25 months |
|
|
From the initiation of study treatment until 30 days after last dose of study treatment or up to study termination date 22May2018.
All treated participants.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Nivolumab + Epacadostat/Platinum Doublet Chemotherapy | Nivolumab + Epacadostat/Platinum Doublet Chemotherapy included the following: Nivolumab was administered intravenously at the protocol-defined dose every 3 weeks. Epacadostat was administered orally at the protocol-defined dose twice daily. Carboplatin was administered intravenously at the protocol-defined dose every 3 weeks for up to 4 cycles. Cisplatin was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Gemcitabine was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Paclitaxel was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Pemetrexed was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Optional continuation maintenance was available every 3 weeks, if eligible. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG001 | Platinum Doublet Chemotherapy | Platinum Doublet Chemotherapy included the following: Carboplatin was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Cisplatin was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Gemcitabine was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Paclitaxel was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Pemetrexed was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Optional continuation maintenance was available every 3 weeks, if eligible. | 1 | 2 | 1 | 2 | 2 | 2 |
| EG002 | Nivolumab + Placebo Combination/Platinum Doublet Chemotherapy | Nivolumab plus placebo in combination with platinum doublet chemotherapy included: Nivolumab was administered intravenously at the protocol-defined dose every 3 weeks. : Matching placebo for epacadostat was administered orally twice daily. Carboplatin was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Cisplatin was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Gemcitabine was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Paclitaxel was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Pemetrexed was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Optional continuation maintenance was available every 3 weeks, if eligible. | 0 | 0 | 0 | 0 | 0 | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dehydration | Metabolism and nutrition disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Osteomyelitis | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 21.0 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
|
Following the first publication, the Institution and/or Principal Investigator may publish data or results from the Study, provided, however, that the Institution and/or Principal Investigator submits the proposed publication to the Sponsor for review at least sixty (60) days prior to the date of the proposed publication. Sponsor may remove from the proposed publication any information that is considered confidential and/or proprietary other than Study data and results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Incyte Corporation | 1-855-463-3463 | medinfo@incyte.com |
| Prot_000.pdf |
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| C565324 | Parkinson Disease 4, Autosomal Dominant Lewy Body |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077594 | Nivolumab |
| C000613752 | epacadostat |
| D016190 | Carboplatin |
| D002945 | Cisplatin |
| D000093542 | Gemcitabine |
| D017239 | Paclitaxel |
| D000068437 | Pemetrexed |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D005971 | Glutamates |
| D024342 | Amino Acids, Acidic |
| D000596 | Amino Acids |
| D000600 | Amino Acids, Dicarboxylic |
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
Platinum Doublet Chemotherapy included the following:
Carboplatin was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Cisplatin was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Gemcitabine was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Paclitaxel was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Pemetrexed was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles.
Optional continuation maintenance was available every 3 weeks, if eligible.
|
Platinum Doublet Chemotherapy included the following: Carboplatin was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Cisplatin was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Gemcitabine was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Paclitaxel was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Pemetrexed was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Optional continuation maintenance was available every 3 weeks, if eligible. |
|
Platinum Doublet Chemotherapy included the following: Carboplatin was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Cisplatin was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Gemcitabine was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Paclitaxel was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Pemetrexed was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Optional continuation maintenance was available every 3 weeks, if eligible. |
|
| Participants |
|
| Participants |
|
| Counts |
|---|
| Participants |
|