Efficacy Analysis of Neoadjuvant Treatment in Lung Cancer Using Low-dose Nivolumab Combined With Chemotherapy

ConditionsLung Cancer, Nonsmall Cell Non-Small Cell Lung Cancer NSCLC

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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

Low-dose nivolumab combined with platinum-based doublet chemotherapy
Drug
Platinum-based neoadjuvant chemotherapy (carboplatin at AUC 5 or 6 combined with either paclitaxel at 175 mg/m² or pemetrexed at 500 mg/m²), administered with nivolumab at 0.3 mg/kg every 21 days for 3 cycles.

Treatment groups

33 Participants

are divided into 1 treatment group

Group A: Low-dose nivolumab combined with platinum-based doublet chemotherapyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Major Pathologic Response

MPR is defined as the proportion of participants who have achieved major pathologic response (on routine hematoxylin and eosin staining, tumors with no more than 10% viable tumor cells) in all participants who have completed the neoadjuvant therapy before surgery.

Time frame

2-3 months

Pathologic Complete Response

Pathological complete response (pCR) is defined as having no residual cancer at the primary site or in regional lymph nodes on pathologic review of the surgical specimen.

Time frame

2-3 months

Secondary outcomes

Adverse Events

TRAE is defined and classified according to NCI-CTCAE v5.0 in all participants.

Time frame

Up to 3 months after the end of treatment

Event-Free-Survival

Event-free survival (EFS) is defined as the length of time (months) from randomization to any of the following events: any progression of disease precluding surgery, progression or recurrence disease based on response evaluation criteria in solid tumors (RECIST) 1.1 after surgery, or death due to any cause. Participants who don't undergo surgery for reason other than progression will be considered to have an event at progression or death.

Time frame

Up to 60 months

R0 resection

R0 resection rate is defined as the proportion of participants who have achieved R0 resection (complete resection with no residual tumor cell in the resection margin) in all participants.

Time frame

Up to 3 months

Other outcomes

Rate of conversion from minimally invasive surgery to open surgery

The frequency at which a minimally invasive procedure needs to be converted to an open surgical approach mid-operation

Time frame

2-3 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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

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