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

Recruiting Phase 3 Interventional Study
NSCLC (Non-small Cell Lung Carcinoma) First Line Therapy Locally Advanced/Metastatic NSCLC
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Other
Participants needed
123 (estimated)
Sponsor
Dr Arvindran A/L Alaga · Government
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About This Trial

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.

Trial Locations
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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 expressi…
Contacts

Dr. Arvindran A/L Alaga

+6047407395

arvindran_82@yahoo.com

CONTACT

LEDANG Coordinating Center

+6047407395

clintrial.ledang@cancerresearch.my

CONTACT