Clinical trial · Interventional
Chemotherapy for Lung Cancer in HIV-positive Patients
Phase II Trial Evaluating the Efficacy and Safety of Carboplatin Plus Pemetrexed in Human Immunodeficiency Virus Positive (HIV+) Patients With Stage III (Not Amenable to Radiation or Inoperable) or Stage IV Nonsquamous Non Small Cell Lung Cancer
NCT01296113CI-TRIAL-00064676CHIVAcompletedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a phase II, multicenter, non-randomized, open-label study evaluating the combination of pemetrexed plus carboplatin in HIV-positive patients with lung cancer.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hiv-positive | — | UNRESOLVED | — |
| Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Chemotherapy | Drug | Chemotherapy | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- A
- interventionNames
- Drug: Chemotherapy
Primary outcomes (1)
- measure
- Disease-Control rate after 4 cycles
- timeFrame
- 3-weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (2)
- BACKGROUNDLavole A, Chouaid C, Baudrin L, Wislez M, Raguin G, Pialoux G, Girard PM, Milleron B, Cadranel J. Effect of highly active antiretroviral therapy on survival of HIV infected patients with non-small-cell lung cancer. Lung Cancer. 2009 Sep;65(3):345-50. doi: 10.1016/j.lungcan.2008.11.018. Epub 2009 Jan 9. PMID 19135758
- RESULTLavole A, Greillier L, Mazieres J, Monnet I, Kiakouama-Maleka L, Quantin X, Spano JP, Lena H, Fraisse P, Janicot H, Audigier-Valette C, Langlais A, Morin F, Makinson A, Cadranel J; French Cooperative Thoracic Intergroup (IFCT). First-line carboplatin plus pemetrexed with pemetrexed maintenance in HIV-positive patients with advanced non-squamous non-small cell lung cancer: the phase II IFCT-1001 CHIVA trial. Eur Respir J. 2020 Aug 27;56(2):1902066. doi: 10.1183/13993003.02066-2019. Print 2020 Aug. PMID 32444410