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

Lilly

Status and phase: Completed; Phase 3

Conditions: Non Small Cell Lung Cancer

Treatments: Drug: Carboplatin; Drug: Paclitaxel; Radiation: Thoracic Radiation Therapy (TRT); Drug: Cisplatin; Drug: Etoposide; Drug: Vinorelbine; Drug: Pemetrexed

Study type: Interventional

Funder types: Industry

Identifiers

NCT00686959

H3E-MC-JMIG (Other Identifier)

11514

Details and patient eligibility

About

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

Enrollment: 598 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participants must have Stage IIIA or IIIIB NSCLC of the non-squamous type
• Participants must have measureable tumor lesions according to the Response Evaluation Criteria in Solid Tumors (RECIST) guidelines or disease that can be evaluated on computerized tomography (CT) scan
• Participants must be physically mobile, take care of themselves and must be up and about and able to perform light activities, such as light housework or office work
• Participants must be 18 years of age or older
• Participants must have lost no more than 10% of their body weight in the previous 3 months
• Women must be sterile, postmenopausal, or on contraception, and men must be sterile or on contraception
• Participants' test results assessing the function of their blood forming tissue, kidneys, liver, and lungs must be satisfactory
• Participants with Stage IIIB NSCLC who have supraclavicular nodal involvement may be entered into this study. However, participants with cervical nodes are not permitted. The upper border of supraclavicular nodes must not extend above the upper border of the lateral end of the clavicle, extended medially.

Exclusion criteria

• Participants cannot have other on-going (uncontrolled) illnesses, including active infections, recent heart problems, or psychiatric illnesses
• Participants who are unable to take vitamins (including injections of vitamin B12) or oral cortisone medication
• Participants who have had a heart attack (myocardial infarction) or other cardiac issues within 6 months of the trial
• Participants who have received other investigational drugs within the last 30 days
• Participants who are unable to stop taking more than 1.3 grams of aspirin on a daily basis or non-steroidal anti-inflammatory agents
• Participants who have diseases considered for surgical treatment as part of their care plan, such as Pancoast or superior sulcus tumors
• Participants who had prior thoracic radiation. However, other prior radiotherapy is allowed. Participants must have recovered from the toxic effects of the treatment prior to study enrollment. Participants may not have received whole pelvis radiation or radiation to more than 25% of their bone marrow. Prior radiotherapy must have been completed at least 30 days prior to study treatment.
• Participants who have a radiation treatment plan that would expose more than 35% of the volume of their lung to 20 gray (Gy) or more of radiation
• Participants who have concurrent cancer from another primary site requiring treatment of any kind within the past 5 years. Exemptions to this will be permitted on a case-by-case basis after prior approval by the Sponsor physician or designate if the investigator believes the participant's risk of recurrence and death is very low. Curatively treated nonmelanoma skin cancer or in situ carcinoma of any origin is allowed. Participants with recurrence of a previously resected lung cancer or who have a second primary lung cancer are ineligible.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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598 participants in 2 patient groups

Arm A: Pemetrexed + Cisplatin and TRT

Experimental group

Description:

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

Treatment:

Drug: Pemetrexed

Drug: Cisplatin

Radiation: Thoracic Radiation Therapy (TRT)

Arm B: Etoposide + Cisplatin and TRT

Active Comparator group

Description:

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

Treatment:

Drug: Vinorelbine

Drug: Cisplatin

Drug: Etoposide

Drug: Carboplatin

Radiation: Thoracic Radiation Therapy (TRT)

Drug: Paclitaxel