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OncoMatch/Clinical Trials/NCT07050043

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

Is NCT07050043 recruiting? Yes, currently enrolling (Jun 2026). This Phase 3 trial studies multiple treatments including Nivolumab 40mg and Cisplatin, Carboplatin, Pemetrexed, Gemcitabine, Paclitaxel, Docetaxel for nsclc (non-small cell lung carcinoma).

Phase 3RecruitingDr Arvindran A/L AlagaNCT07050043Data as of Jun 2026Location: Malaysia

Treatment: Nivolumab 40mg · Cisplatin, Carboplatin, Pemetrexed, Gemcitabine, Paclitaxel, DocetaxelThis 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.

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Extracted eligibility criteria

Treatments studied

Immunotherapy

Nivolumab 40mg

Chemotherapy

Cisplatin, Carboplatin, Pemetrexed, Gemcitabine, Paclitaxel, Docetaxel

Cancer type

Non-Small Cell Lung Carcinoma

Biomarker criteria

Required: EGFR mutation (wild-type)

Presence of EGFR, ALK , ROS1 mutation(s) [excluded]

Required: ALK mutation (wild-type)

Presence of EGFR, ALK , ROS1 mutation(s) [excluded]

Required: ROS1 mutation (wild-type)

Presence of EGFR, ALK , ROS1 mutation(s) [excluded]

Required: PD-L1 (CD274) expression (documented)

with documented PD-L1 expression

Disease stage

Required: Stage IIIB, IV

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

No prior treatment (treatment-naive required)
Max 0 prior lines

Cannot have received: anti-PD-1 therapy

Prior treatment with any anti-PD-1, anti-PD-L1 or any other antibody targeting an immune checkpoint

Lab requirements

Blood counts

adequate organ function including the following laboratory values at the screening visit as per Table 2

Kidney function

adequate organ function including the following laboratory values at the screening visit as per Table 2

Liver function

adequate organ function including the following laboratory values at the screening visit as per Table 2

Participants must have adequate organ function including the following laboratory values at the screening visit as per Table 2

Structured fields extracted by AI. May contain errors — verify against the official protocol.

Frequently asked questions

Is NCT07050043 currently recruiting?

Yes, this trial is currently recruiting patients.

Can patients have received prior systemic therapy?

No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.

Does this trial require EGFR?

Yes, EGFR mutation is a required biomarker for enrollment.

Does this trial require ALK?

Yes, ALK mutation is a required biomarker for enrollment.

Does this trial require ROS1?

Yes, ROS1 mutation is a required biomarker for enrollment.

What disease stage is eligible?

Stage IIIB or IV is required.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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