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

A Phase III RCT Comparing Low Dose Immunotherapy (Nivolumab) Combined With Standard Chemotherapy vs Standard Chemotherapy as First-line Treatment in Patients With Locally Advanced or Metastatic NSCLC

Low Dose Nivolumab With Chemotherapy vs Standard Chemotherapy as First-Line Treatment in Advanced or Metastatic NSCLC (NCT07050043) is a Phase 3 interventional studying NSCLC (Non-small Cell Lung Carcinoma) and First Line Therapy, sponsored by Dr Arvindran A/L Alaga. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

What Stage of Research Is This?

Phase 3 trials confirm efficacy and safety in large patient groups (often 300–3,000+) and form the evidence base for an FDA approval submission. For NSCLC (Non-small Cell Lung Carcinoma), Phase 3 studies typically randomize participants between the investigational treatment and either a placebo or current standard of care. A successful Phase 3 result is the threshold most treatments need to clear before regulatory approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 123 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused NSCLC (Non-small Cell Lung Carcinoma) subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Male/female participants who are at least 18 years of age on the day of signing willing to sign a consent form. 2. diagnosed by tissue sample (biopsy-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 your organs (liver, kidneys, etc.) are working well enough based on blood tests 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, ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

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.

Treatments Being Tested

DRUG

Nivolumab 40mg

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

DRUG

Cisplatin, Carboplatin, Pemetrexed, Gemcitabine, Paclitaxel, Docetaxel

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

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Hospital Sultanah Bahiyah

Alor Star, Kedah, Malaysia

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07050043), the sponsor (Dr Arvindran A/L Alaga), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07050043 clinical trial studying?

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. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT07050043?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07050043?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT07050043. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07050043. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-06-07 · Data from ClinicalTrials.gov.