Efficacy Analysis of Neoadjuvant Treatment in Lung Cancer Using Low-dose Nivolumab Combined With Chemotherapy
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorAline Fusco Fares, MD
About this trial
The primary objective of this study is to assess the major pathological response (MPR) rate and pathologic complete response (pCR) rate in stage IB-IIIA non-small cell lung cancer (NSCLC) treated with a low dose of neoadjuvant immunotherapy combined with platinum doublet.
Eligibility criteria
Qualifiers
Able to provide a signed Informed Consent Form (ICF), indicating agreement to comply with the requirements and restrictions in the ICF and protocol.
Male or female, aged 18 years or older.
Diagnosed with non-small cell lung cancer (NSCLC) with clinical staging IB, II, or IIIA.
Receiving treatment at Hospital de Base.
Disqualifiers
Refusal to sign the Informed Consent Form (ICF).
NSCLC clinical stages IA, IIIB N3, IIIC, IVA, and IVB.
Tumors with T4 invasion of the aorta, esophagus, and/or heart; or presence of bulky N2 disease.
Tumor deemed unresectable.
Trial design
Treatments tested in this trial
- Low-dose nivolumab combined with platinum-based doublet chemotherapy
Treatment groups
33 Participants
are divided into 1 treatment groupSponsors and collaborators
Aline Fusco Fares, MD
Lead sponsor
Fundação Faculdade Regional de Medicina de São José do Rio Preto
Sponsor institution
Hospital de Base
Collaborator
Source ClinicalTrials.gov