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Low Dose Nivolumab With Chemotherapy vs Standard Chemotherapy as First-Line Treatment in Advanced or Metastatic NSCLC | Clinical Trials | Clareo Health

RECRUITINGPHASE3

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

NCT07050043•Dr Arvindran A/L Alaga

View on ClinicalTrials.gov

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.

Detailed Description

Eligible subjects who satisfy the inclusion and exclusion criteria will be randomized 2:1 into 2 arms (Low dose nivolumab arm consisting of six-weekly 40mg Nivolumab plus 4-6\* cycles of Cisplatin or Carboplatin plus Pemetrexed or Gemcitabine or Docetaxel or Paclitaxel per local practice, versus standard chemotherapy alone, consisting 4-6\* cycles of Cisplatin or Carboplatin plus Pemetrexed or Gemcitabine or Docetaxel or Paclitaxel per local practice.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Male/female participants who are at least 18 years of age on the day of signing informed consent.

Exclusion Criteria

•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,
+14 more criteria

Locations (1)

Hospital Sultanah Bahiyah

Alor Star, Kedah, Malaysia

Key Dates

Start Date

May 19, 2025

Primary Completion Date

December 31, 2030

Completion Date

December 31, 2030

Last Updated

July 3, 2025

Enrollment

123

ESTIMATED participants

Conditions

NSCLC (Non-small Cell Lung Carcinoma)First Line TherapyLocally Advanced/Metastatic NSCLC

Interventions

Nivolumab 40mg

DRUG

Cisplatin, Carboplatin, Pemetrexed, Gemcitabine, Paclitaxel, Docetaxel

DRUG

Contacts

Dr. Arvindran A/L Alaga

CONTACT

+6047407395 arvindran_82@yahoo.com

LEDANG Coordinating Center

CONTACT

+6047407395 clintrial.ledang@cancerresearch.my

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 3, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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