Chemotherapy and Radiation in Treating Participants With Stage 3 Non-Small Cell Lung Cancer

Conditions

• Non Small Cell Lung Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Pemetrexed — DRUG
  infusion over 10 minutes
• Cisplatin — DRUG
  infusion over 60 minutes with adequate anti-emetic treatment and appropriate hydration per local practice guidelines
• Etoposide — DRUG
  administered per local practice guidelines over a minimum of 30 minutes
• Vinorelbine — DRUG
  administered over 6-10 minutes infusion per local practice guidelines
• Paclitaxel — DRUG
  administered as a 3-hour infusion
• Carboplatin — DRUG
  administered per local practice guidelines over 30 minutes
• Thoracic Radiation Therapy (TRT) — RADIATION

Study Details

This study will compare the overall survival of participants with locally-advanced, Stage III Non-Small Cell Lung Cancer (NSCLC) with nonsquamous cell histology.

Key Dates

Start date

Sep 30, 2008

Status verified

May 2016

Primary completion

Oct 31, 2014

Completion

Nov 30, 2014

Study Design

Enrollment

598 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm A: Pemetrexed + Cisplatin and TRT
  Participants were treated with Pemetrexed plus Cisplatin and concurrent thoracic radiation therapy (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 milligrams per meter squared (mg/m\^2), intravenous (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 Gray \[Gy\] 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
• Active Comparator: 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

Primary Outcome Measure

Overall Survival [ Time Frame: Baseline to Date of Death from Any Cause (Up to 71.4 Months) ]

Locations (50)

Find similar trials in Birmingham, AL

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