Cisplatin-Pemetrexed Compared With Carboplatin-Paclitaxel-Bevacizumab in KRAS Mutated Non-small Cell Lung Cancer

• Status: Recruiting
• Trial end date: 2021-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether carboplatin-paclitaxel-bevacizumab results in a prolonged progression free survival compared to cisplatin-pemetrexed as first line treatment in patients with KRAS mutated non-small cell lung cancer.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Netherlands Cancer Institute
• Collaborator: Dutch Society of Physicians for Pulmonology and Tuberculosis
• Treatments: Albumin-Bound Paclitaxel; Bevacizumab; Carboplatin; Cisplatin; Paclitaxel; Pemetrexed

Criteria

Inclusion Criteria:

1. Histologically or cytologically confirmed (non-squamous) NSCLC incurable locally advanced or metastatic (stage IIIB and stage IV) disease.

2. Documented KRAS mutation

3. Chemotherapy-naive NSCLC patients. Adjuvant chemotherapy or chemoradiotherapy is allowed when given > 1 year for study entry. Previous anti-PD(L1) therapy for advanced disease is allowed.

4. At least one unidimensionally measurable lesion meeting RECIST1.1.

5. ECOG PS 0-2

6. Age ≥ 18 years

7. Adequate organ function, including:

• Adequate bone marrow reserve: ANC ≥ 1.5 x 109/L, platelets ≥ 100 x 109/L.

• Hepatic: bilirubin ≤1.5 x ULN, AP, ALT, AST ≤ 3.0 x ULN AP, ALT, and AST ≤5 xULN is acceptable if the liver has tumor involvement

• Renal: calculated creatinine clearance ≥ 60 ml/min based on the Cockroft-Gault formula.

• Urine protein (dip-stick) < 2 +; when ≥ 2 +: 24 hours urine protein ≤ 1 gr.

8. Signed informed consent

9. Male and female patients with reproductive potential must use an approved contraceptive method, if appropriate. Female patients with childbearing potential must have a negative serum pregnancy test within 7 days prior to study enrollment.

Exclusion Criteria:

1. Pregnant or lactating women

2. Clinically significant (i.e. active) cardiovascular disease: congestive heart failure >NYHA class 2; CVA or myocardial infarction < 6 months prior to study entry; uncontrolled hypertension (blood pressure systolic > 150 mmHg and/or diastolic > 100 mmHg)

3. History of hemoptysis ≥ grade 2 (bright red blood of at least 2,5 ml in the last 3 months)

4. Evidence of tumor invading major blood vessels on imaging (i.e. superior vena cava or pulmonary artery)

5. Patients with evidence or history of bleeding diathesis

6. Non-healing wound or ulcer