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

Launched by DR ARVINDRAN A/L ALAGA · Jun 25, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment option for people with advanced or metastatic non-small cell lung cancer (NSCLC), which is a common type of lung cancer. The trial compares the usual chemotherapy treatment to a combination of chemotherapy with a low dose of a medicine called Nivolumab, which helps the immune system fight cancer. The goal is to see if adding this low dose of Nivolumab is safer and more effective than chemotherapy alone for patients who have not received treatment for their advanced lung cancer before.

People eligible to join this study are adults with confirmed advanced NSCLC who have not yet been treated for their advanced disease and have tumors that show a specific protein called PD-L1. Participants must be well enough to carry on normal activities and have at least one measurable tumor. Those with certain genetic mutations, other serious health issues, or previous treatment with similar immune medicines are not eligible. If you join, you will be randomly assigned to receive either standard chemotherapy or chemotherapy plus low-dose Nivolumab, and your health and cancer will be closely monitored throughout the treatment. This study is currently recruiting, and it offers a chance to receive a promising new treatment while contributing to lung cancer research.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Male/female participants who are at least 18 years of age on the day of signing informed consent.
• • 2. 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.
• • 3. 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.
• • 4. 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.
• • 5. At least 1 measurable lesion by RECIST 1.1 in solid tumors criteria.
• 6. Participants must have adequate organ function including the following laboratory values at the screening visit as per Table 2:
• 7. If a participant has brain or meningeal metastases, the participant must meet the following criteria:
• • 1. 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.
• • 2. Carcinomatous meningitis is excluded regardless of clinical stability.
• • 8. 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.
• 9. A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:
• • 1. Not a woman of childbearing potential (WOCBP), OR,
• • 2. 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.
• • 10. 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.
• Exclusion Criteria:
• • 1. Presence of EGFR, ALK , ROS1 mutation(s).
• • 2. 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.
• • 3. Prior treatment with any anti-PD-1, anti-PD-L1 or any other antibody targeting an immune checkpoint.
• • 4. Use of any live vaccines against infectious diseases within 28 days of first dose of IP(s).
• • 5. 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.
• • 6. 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).
• • 7. Active hepatitis B and C infection or human immunodeficiency virus antibody (HIV-1 and/or HIV-2) positive at screening.
• • 8. Known hypersensitivity to recombinant proteins, or any excipient contained in the IP formulations.
• • 9. Known history of autoimmune disease currently on immunosuppressive medications.
• • 10. Known history of second malignancy within two years prior enrolment.
• • 11. Prognosis of three months or less.
• • 12. 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.