Low Dose Nivolumab With Chemotherapy vs Standard Chemotherapy as First-Line Treatment in Advanced or Metastatic NSCLC

NCT07050043 | Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: IIT-LEDANG2023001NIH/800-3/2/2 Jilid 18 (38)
• Study Type: interventional
• Target: 123
• Locations: 1 country
• Sites: 1

Brief Summary

This is a multicenter, two-arm randomized, parallel group design trial to evaluate superiority and safety of low dose Nivolumab (40mg) combined with standard chemotherapy versus standard chemotherapy alone in patients with non-small cell lung cancer.

Conditions

NSCLC (Non-small Cell Lung Carcinoma); First Line Therapy; Locally Advanced/Metastatic NSCLC

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival (PFS)

  Determine the PFS of six-weekly Nivolumab 40mg combined with standard chemotherapy versus standard chemotherapy alone in NSCLC

  From randomization to either the date of progression or death from any cause (whichever comes first) - up to 36 months

Secondary Outcomes (9)

• Overall Survival (OS)

  From the date of treatment commencement to the date death from any cause or the date of the last follow-up before final analysis (whichever comes first) - up to 36 months

• Patient-Reported Outcome Measure (PROM)

  From the baseline until the end of treatment follow up or the last study follow up related to adverse event - up to 24 months

• PROM using EORTC QLQ-C30

  From the baseline until the end of treatment follow up or the last study follow up related to adverse event - up to 24 months

• PROM using EQ-5D-5L

  From the baseline until the end of treatment follow up or the last study follow up related to adverse event - up to 24 months

• PROM using NSCLC-SAQ

  From the baseline until the end of treatment follow up or the last study follow up related to adverse event - up to 24 months

Study Arms (2)

Nivolumab + Standard Chemotherapy

EXPERIMENTAL

Patient will be receiving of low dose Nivolumab (40mg) combined with standard chemotherapy

Drug: Nivolumab 40mg; Drug: Cisplatin, Carboplatin, Pemetrexed, Gemcitabine, Paclitaxel, Docetaxel

Standard Chemotherapy

ACTIVE COMPARATOR

Patient will be receiving standard chemotherapy alone.

Drug: Cisplatin, Carboplatin, Pemetrexed, Gemcitabine, Paclitaxel, Docetaxel

Interventions

Nivolumab 40mg DRUG

Nivolumab is an immunotherapy medicine used to treat several cancers, including lung cancer.

Also known as: Opdivo

Nivolumab + Standard Chemotherapy

Cisplatin, Carboplatin, Pemetrexed, Gemcitabine, Paclitaxel, Docetaxel DRUG

Cisplatin, carboplatin, pemetrexed, paclitaxel, Gemcitabine, and docetaxel are chemotherapy drugs used to treat various types of cancer, including non-small cell lung cancer.

Also known as: CDDP, Paraplatin, Taxotere, CBDCA, dFdC, PTX

Nivolumab + Standard Chemotherapy; Standard Chemotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male/female participants who are at least 18 years of age on the day of signing informed consent.
• Histologically confirmed, treatment naïve, locally advanced, or metastatic (stage IIIB - IV (per AJCC version 8), squamous or non-squamous NSCLC with documented PD-L1 expression and is not eligible for definitive chemo-radiation curative therapy and surgery.
• Patients must be treatment naïve with respect to locally advanced or metastatic disease. Patients who received prior treatment with curative intent for early stage disease and develop recurrent advanced/ metastatic disease must have completed treatment at least 6 months prior to first dose of IP.
• Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. Evaluation of ECOG is to be performed within 7 days prior to the first dose of study intervention.
• At least 1 measurable lesion by RECIST 1.1 in solid tumors criteria.
• Participants must have adequate organ function including the following laboratory values at the screening visit as per Table 2:
• If a participant has brain or meningeal metastases, the participant must meet the following criteria:
• Metastatic brain lesions do not require immediate intervention. Note: Asymptomatic, treated and stable as well as not requiring steroids for at least 2 weeks prior to start study Treatment.
• Carcinomatous meningitis is excluded regardless of clinical stability.
• A male participant must agree to use a contraception starting with the first dose of study treatment through the treatment period and for at least 90 days after the last dose of study treatment and refrain from donating sperm during this period.
• A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:
• Not a woman of childbearing potential (WOCBP), OR,
• A WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 180 days after the last dose of study treatment.
• Can provide evaluable archival tumor tissue sample or willing to provide tissue from newly obtained core or excisional biopsy or fine needle aspirate (FNA) cell block form of tumor lesion not previously irradiated. Note: Formalin fixed, paraffin embedded (FFPE) tissue blocks or slides allowed.

You may not qualify if:

• Presence of EGFR, ALK , ROS1 mutation(s).
• Patients with locally advanced disease who can receive other potentially curative therapies, such as patients who can afford to pay for or can otherwise access clinically approved doses of immunotherapy.
• Prior treatment with any anti-PD-1, anti-PD-L1 or any other antibody targeting an immune checkpoint.
• Use of any live vaccines against infectious diseases within 28 days of first dose of IP(s).
• Underlying medical conditions that, in the Investigator's or Sponsor PI's opinion, will make the administration of IP(s) hazardous, including but not limited to interstitial lung disease, including history of interstitial lung disease or non-infectious pneumonitis (lymphangitic spread of NSCLC is not disqualifying), or active viral, bacterial, or fungal infections requiring parenteral treatment within 14 days of the initiation of the IP.
• Concurrent medical condition requiring the use of supra-physiologic doses of corticosteroids (\> 10 mg/day of oral prednisone or equivalent) or immunosuppressive medications (absorbable topical corticosteroids are not excluded).
• Active hepatitis B and C infection or human immunodeficiency virus antibody (HIV-1 and/or HIV-2) positive at screening.
• Known hypersensitivity to recombinant proteins, or any excipient contained in the IP formulations.
• Known history of autoimmune disease currently on immunosuppressive medications.
• Known history of second malignancy within two years prior enrolment.
• Prognosis of three months or less.
• A WOCBP who has a positive urine pregnancy test within 72 hours prior to treatment allocation. If the urine test positive or cannot be confirmed as negative, a serum pregnancy test will be required.

Sponsors & Collaborators

• Dr Arvindran A/L Alaga: lead

Study Sites (1)

Hospital Sultanah Bahiyah

Alor Star, Kedah, 05460, Malaysia

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Nivolumab; Cisplatin; Carboplatin; Pemetrexed; Gemcitabine; Paclitaxel; Docetaxel

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Coordination Complexes; Organic Chemicals; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Dicarboxylic; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes

Study Officials

• Dr. Arvindran A/L Alaga

  Hospital Sultanah Bahiyah

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr. Arvindran A/L Alaga

CONTACT

+6047407395; arvindran_82@yahoo.com

LEDANG Coordinating Center

CONTACT

+6047407395; clintrial.ledang@cancerresearch.my

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Consultant Respiratory Physician

Study Record Dates

• First Submitted: May 15, 2025
• First Posted: July 3, 2025
• Study Start: May 19, 2025
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2030
• Last Updated: July 3, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)