Clinical trial NCT06667154: Efficacy Analysis of Neoadjuvant Treatment in Lung Cancer Using Low-dose Nivolumab Combined With Chemotherapy
Official title: Efficacy Analysis of Neoadjuvant Treatment in Lung Cancer Using Low-Dose Nivolumab Combined With Chemotherapy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Lung Cancer, Nonsmall Cell
Non-Small Cell Lung Cancer NSCLC
Keywords: Low Dose Immunotherapy
Neoadjuvant immunotherapy
Non-Small-Cell-Lung-Cancer
Lead sponsor: Fundação Faculdade Regional de Medicina de São José do Rio Preto
Sponsor class: OTHER
Collaborators: name: Hospital de Base de Sao Jose do Rio Preto
First posted: 2024-10-31
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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: Inclusion Criteria:

* 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.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at enrollment, with no decline from two weeks prior to the baseline period or the day of the first dose.
* Tumor sample meets the following requirements:
* Negative for EGFR gene expression.
* Negative for ALK and ROS1 protein expression.
* PD-L1 protein expression documented and assessable.
* Tumor is considered resectable upon initial assessment by three thoracic oncology surgeons (IR, CM, and HN) following a multidisciplinary review.
* Adequate organ and bone marrow function as defined below:
* Hemoglobin: ≥ 9.0 g/dL\*
* Absolute neutrophil count: ≥ 1.5 × 10\^9 /L\*
* Platelet count: ≥ 100 × 10\^9 /L\*
* \*Note: Granulocyte colony-stimulating factor (G-CSF), platelet transfusions, and blood transfusions are not permitted to meet these values.
* Serum bilirubin: ≤ 1.5 × upper limit of normal (ULN), except for participants with confirmed Gilbert syndrome, who may be included upon physician consultation.
* ALT and AST: ≤ 2.5 × ULN.
* Creatinine clearance: ≥ 50 mL/min (calculated using the Cockcroft and Gault formula).
* Life expectancy greater than six months prior to randomization.

Exclusion Criteria:

* 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.
* Prior systemic anticancer therapy for NSCLC, including chemotherapy, biologic therapy, immunotherapy, or any investigational drugs.
* History of another primary malignancy, with exceptions for:
* Malignancies treated with curative intent and no active disease for ≥ 2 years before the first dose of investigational product (IP) and with a low risk of recurrence.
* Adequately treated non-melanoma skin cancer or lentigo maligna with no evidence of disease.
* Adequately treated carcinoma in situ with no evidence of disease.
* Incomplete basic medical information in the electronic medical record.
* Positive for EGFR gene expression.
* Positive for ALK protein expression.
* No available data on PD-L1 protein expression.
* Positive for ROS1 protein expression.
* Pregnant or breastfeeding at the time of enrollment.

Primary outcomes:
measure: Major Pathologic Response
timeFrame: 2-3 months
measure: Pathologic Complete Response
timeFrame: 2-3 months
Secondary outcomes:
measure: Adverse Events
timeFrame: Up to 3 months after the end of treatment
measure: Event-Free-Survival
timeFrame: Up to 60 months
measure: R0 resection
timeFrame: Up to 3 months
Other outcomes:
measure: Rate of conversion from minimally invasive surgery to open surgery
timeFrame: 2-3 months
Locations:
city: Sao Jose Do Rio Preto
country: Brazil
facility: Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto
state: SAO Paulo
Study officials:
affiliation: FUNDACAO FACULDADE REGIONAL DE MEDICINA DE SAO JOSE DO RIO PRETO
name: JOAO A SOLER, MD
role: PRINCIPAL_INVESTIGATOR
References: