Phase 2b Study of Cetuximab With Platinum-Based Chemo as First Line Treatment of Recurrent or Advanced 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 601 is above the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.

Lead sponsor

Accelerated Community Oncology Research Network is the lead sponsor of 15 studies on the registry; none are open to participants now.

Study arms

• Active comparator
  Paclitaxel, Carboplatin, Cetuximab (Arm A)

  Patients with squamous or non-squamous histologies will receive carboplatin and paclitaxel for a minimum of four and a maximum of six 21-day cycles, plus cetuximab, and then enter a maintenance phase with single-agent cetuximab. Cetuximab will be given on Day 1, and weekly during chemotherapy, followed by biweekly administration during the maintenance period. The choice of delivering four, five or six cycles of chemotherapy is at the investigator's discretion.

  Drug: Cetuximab · Drug: Paclitaxel · Drug: Carboplatin

• Active comparator
  Platinum, Gemcitabine, Cetuximab (Arm B)

  Patients with squamous or non-squamous histologies will receive gemcitabine with either carboplatin or cisplatin for a minimum of four and a maximum of six 21-day cycles, plus cetuximab, and then enter a maintenance phase with single-agent cetuximab. Cetuximab will be given on Day 1, and weekly during chemotherapy, followed by biweekly administration during the maintenance period. The choice of delivering four, five or six cycles of chemotherapy is at the investigator's discretion. The choice of platinum-based chemotherapy is also at the investigator's discretion.

  Drug: Cetuximab · Drug: Carboplatin · Drug: Gemcitabine · Drug: Cisplatin

• Active comparator
  Platinum, Pemetrexed, Cetuximab (Arm C)

  Patients with squamous histology will receive pemetrexed and either carboplatin or cisplatin for a minimum of four and a maximum of six 21-day cycles, plus cetuximab, and then enter a maintenance phase with single-agent cetuximab. Cetuximab will be given on Day 1, and weekly during chemotherapy, followed by biweekly administration during the maintenance period. The choice of delivering four, five or six cycles of chemotherapy is at the investigator's discretion. The choice of platinum-based chemotherapy is also at the investigator's discretion. Patients with non-squamous histology are not eligible for this arm.

  Drug: Cetuximab · Drug: Carboplatin · Drug: Cisplatin

Interventions

• DrugCetuximab

  Cetuximab will be administered at a loading dose of 400 mg/m2 on Day 1, Cycle 1 and at a dose of 250 mg/m2 weekly during chemotherapy. During the maintenance period, cetuximab will be dosed at 500 mg/m2 every two weeks.

  Also known as: Erbitux

• DrugPaclitaxel

  Paclitaxel 200 mg/m2 Day 1 every 21 days

  Also known as: Taxol

• DrugCarboplatin

  Carboplatin AUC 6 Day 1 every 21 days

  Also known as: Paraplatin

• DrugGemcitabine

  Gemcitabine 1,000 mg/m2 Days 1 and 8 every 21 days

  Also known as: Gemzar

• DrugCisplatin

  Cisplatin 75 mg/m2 Day I every 21 days

  Also known as: Platinol

Primary outcomes

1. Overall Survival by Treatment Arm

   Time frame: Survival was measured from the date of randomization to date of death due to any cause, assessed up to 36 months. Subjects who were alive at the date of last contact were censored at the date of last contact.

Secondary outcomes

1. 1-year Survival by Treatment Arm

   Time frame: Survival was measured from the date of randomization to date of death due to any cause, assessed up to 36 months. Subjects who were alive at the date of last contact were censored at the date of last contact.

2. Overall Survival by Histology

   Time frame: Survival was measured from the date of randomization to date of death due to any cause, assessed up to 36 months. Subjects who were alive at the date of last contact were censored at the date of last contact.

Baseline characteristics