Chemotherapy for Lung Cancer in HIV-positive Patients (CHIVA)

Inclusion Criteria:

• NSCLC histologically (highly recommended) and/or cytologically confirmed, stage III (non-irradiable or inoperable) or stage IV (according to 2009 TNM classification), with other than predominantly squamous histology
• HIV seropositivity (previous or inaugural), irrespective of CD4 count or viral load
• Presence of at least one measurable lesion (RECIST v1.1)
• Subject having signed the informed consent form,
• Subject who, in the investigator's opinion, will be able to comply with the requirements and constraints of the study
• Age ≥ 18 years ≤ 75 years,
• WHO performance status: 0, 1 or 2
• Weight loss ≤ 10% of total body weight in the month before inclusion
• Estimated life expectancy ≥ 1 month,
• Covered by health insurance

Exclusion Criteria:

• Bronchial cancer already treated (other than endoscopic deobstruction)
• Cancer which is amenable to surgery or radiation (curative),
• Squamous cell lung cancer or mixed small cell and non-small cell cancer, small cell lung cancer
• Creatinine clearance (MDRD) < 45 mL/min
• Severe hypersensitivity to any of the study products or excipients
• Severe disease or uncontrolled systemic disease (unstable or decompensated respiratory disease, cardiac, hepatic or renal disease, uncontrolled opportunistic infection)
• Significant abnormality in CBC-platelets (Hb <9 g/dL, PNN <1500 / mm3, platelets < 100,000 / mm3)
• Significant abnormality in liver tests (AST, ALT > 3x ULN, and <5 in case of liver metastases),
• Women of childbearing age without effective contraception; pregnant or breastfeeding women
• Subject who cannot take vitamin B12, folic acid or corticosteroids
• Diffuse interstitial pneumonia
• Any geographical situation or psychological condition that precludes full understanding and compliance with the protocol