First Line Chemotherapy Treatment of Advanced Non-Small Cell Lung Cancer (NSCLC)

Browse trials for

• Lung Neoplasms 7,243
• Carcinoma, Non-Small-Cell Lung 6,488

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.

This study's enrollment of 218 is above the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.

Lead sponsor

Eli Lilly and Company is the lead sponsor of 2,048 studies on the registry; 140 are open to participants now.

Of its 521 completed or terminated interventional studies of FDA-regulated products, 341 (65%) have results posted.

Study arms

• Experimental
  Enzastaurin/Pemetrexed/Carboplatin

  Drug: enzastaurin · Drug: pemetrexed · Drug: carboplatin

• Experimental
  Pemetrexed/Carboplatin

  Drug: pemetrexed · Drug: carboplatin

• Active comparator
  Docetaxel/Carboplatin

  Drug: docetaxel · Drug: carboplatin

Interventions

• Drugenzastaurin

  1125-1200 milligrams (mg) loading dose then 500 mg, oral, daily, until disease progression

  Also known as: LY317615

• Drugpemetrexed

  500 milligrams per square meter (mg/m\^2), intravenous (IV), once every (q) 21 days, six 21 day cycles or progressive disease

  Also known as: LY231514, Alimta

• Drugdocetaxel

  75 mg/m\^2, IV, q 21 days, six 21 day cycles or progressive disease

• Drugcarboplatin

  Area under the curve (AUC) 6, IV, q 21 days, six 21 day cycles or progressive disease

Primary outcomes

1. Time to Disease Progression

   Time to disease progression was defined as the time from randomization to the first date of documented disease progression or death if the participant dies due to disease progression. Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST, version 1.0) criteria. Progressive disease (PD) was defined as having at least a 20% increase in sum of the longest diameter of target lesions. For participants who have not had documented disease progression, time to disease progression was censored at the date of death or date of last visit. For participants who received other anti-tumor therapy prior to disease progression, time to disease progression was censored at the first available date of other anti-tumor therapy.

   Time frame: Baseline to measured PD up to 22.3 months

Secondary outcomes

1. Tumor Biomarkers Associated With Clinical Outcomes

   As specified in the protocol, tumor biomarker samples were collected from participants on the pemetrexed arms only but were not intended to be analyzed at the individual study level.

   Time frame: Baseline, Cycle 1, Cycle 2 (21-day cycle each), and 30-day post study treatment follow-up

2. Assessment of Smoking History (All Participants) and Hormone Replacement Therapy (Female Participants Only) Associated With Clinical Outcomes

   Data for smoking history and hormone replacement therapy were collected but were not intended to be analyzed at the individual study level.

   Time frame: Baseline

3. Number of Participants With Adverse Events (AEs) or Deaths

   Data presented are the number of participants who experienced 1 or more AEs or any serious AEs (SAEs) regardless of causality, or deaths during the study including 30 days after treatment discontinuation. A summary of SAEs and other non-serious AEs is located in the Reported Adverse Events section of this report.

   Time frame: Baseline through study completion up to 6 cycles (21-day cycle each) and 30-day safety follow-up

4. Change From Baseline in Total Functional Assessment of Cancer Therapy-Lung (FACT-L) Scale

   The FACT-L version 4 scale is used to assess health-related quality of life (HRQoL) in participants with lung cancer. The FACT-L has 5 subscales: Physical Well-Being (PWB), Social and Family Well-Being (SFWB) and Functional Well-Being (FWB) subscales which include 7 items each, Emotional Well-Being (EWB) subscale which includes 6 items, and a Lung-Cancer Specific (LCS) subscale which include 7 items. Total FACT-L is the sum of all 5 subscales. Each item is scored from 0 to 4 giving a total overall score from 0 equal to "worst quality of life" to 136 equal to "best quality of life". The Least Square (LS) mean was calculated using an analysis of covariance (ANCOVA) model adjusted for change scores and baseline scores.

   Time frame: Baseline, Cycle 1 (Week 3), Cycle 2 (Week 6), Cycle 3 (Week 9), Cycle 4 (Week 12), Cycle 5 (Week 15) and Cycle 6 (Week 18) [21-day cycle each]

5. Change From Baseline in Total Functional Assessment of Cancer Therapy -Taxane (FACT-Taxane) Scale

   The FACT-Taxane version 4 scale is used to assess HRQoL in participants receiving taxane chemotherapy. The FACT-taxane has 5 subscales: PWB, SFWB, and FWB subscales which include 7 items each, EWB subscale which includes 6 items, and a taxane subscale which include 16 items and has two domains (neurotoxicity and taxane). Total FACT-Taxane is the sum of all the 5 subscales. Each item is scored from 0 to 4 giving a total overall score from 0 "worst quality of life" to 172 "best quality of life". The LS mean was calculated using an ANCOVA model adjusted for change scores and baseline scores.

   Time frame: Baseline, Cycle 1 (Week 3), Cycle 2 (Week 6), Cycle 3 (Week 9), Cycle 4 (Week 12), Cycle 5 (Week 15) and Cycle 6 (Week 18) [21-day cycle each]

6. Overall Survival (OS)

   OS was the duration from the date of randomization to the date of death from any cause. For participants who were alive, OS was censored at the date of last follow-up visit or at the date of last contact.

   Time frame: Baseline to date of death from any cause up to 35 months

7. Number of Participants With Complete Response (CR) or Partial Response (PR) [Tumor Response]

   Response was defined using RECIST, version 1.0 criteria. Participants with a best response of CR or PR were considered to have had a tumor response. CR was defined as the disappearance of all target lesions. PR was defined as having at least a 30% decrease in sum of longest diameter of target lesions.

   Time frame: Baseline to measured PD up to 22.3 months

8. Duration of CR or PR (Duration of Response)

   The duration of a CR or PR was defined as the time from first objective status assessment of CR or PR to the first time of progression or death due to any cause. Response was defined using RECIST, version 1.0 criteria. CR was defined as the disappearance of all target lesions. PR was defined as having at least a 30% decrease in sum of longest diameter of target lesions.

   Time frame: Date of first response to the date of progression or death due to any cause up to 22.3 months

9. Time-to-Treatment Failure (TTF)

   TTF was defined as the time from randomization to the first observation of PD, death due to any cause, or early discontinuation of treatment. Response was defined using RECIST, version 1.0 criteria. PD was defined as having at least a 20% increase in sum of longest diameter of target lesions. TTF was censored at the date of the last follow-up visit for participants who did not discontinue early, who were still alive, and who have not progressed.

   Time frame: Baseline to stopping treatment up to 14.1 months

Baseline characteristics

Publications

• Socinski MA, Raju RN, Stinchcombe T, Kocs DM, Couch LS, Barrera D, Rousey SR, Choksi JK, Jotte R, Patt DA, Periman PO, Schlossberg HR, Weissman CH, Wang Y, Asmar L, Pritchard S, Bromund J, Peng G, Treat J, Obasaju CK. Randomized, phase II trial of pemetrexed and carboplatin with or without enzastaurin versus docetaxel and carboplatin as first-line treatment of patients with stage IIIB/IV non-small cell lung cancer. J Thorac Oncol. 2010 Dec;5(12):1963-9. doi: 10.1097/JTO.0b013e3181fd42eb. PubMed 21102260 ↗