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

NCT ID: NCT07050043

Last Updated: 2025-07-03

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 123 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-19
• Study Completion Date: 2030-12-31

Brief 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.

Conditions

NSCLC (Non-small Cell Lung Carcinoma); First Line Therapy; Locally Advanced/Metastatic NSCLC

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Nivolumab + Standard Chemotherapy

Patient will be receiving of low dose Nivolumab (40mg) combined with standard chemotherapy

Group Type: EXPERIMENTAL

Nivolumab 40mg

Intervention Type: DRUG

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

Cisplatin, Carboplatin, Pemetrexed, Gemcitabine, Paclitaxel, Docetaxel

Intervention Type: DRUG

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

Standard Chemotherapy

Patient will be receiving standard chemotherapy alone.

Group Type: ACTIVE_COMPARATOR

Cisplatin, Carboplatin, Pemetrexed, Gemcitabine, Paclitaxel, Docetaxel

Intervention Type: DRUG

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

Interventions

Nivolumab 40mg

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

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

Opdivo; CDDP; Paraplatin; Taxotere; CBDCA; dFdC; PTX

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dr Arvindran A/L Alaga

OTHER_GOV

Sponsor Role: lead

Responsible Party

Dr Arvindran A/L Alaga

Consultant Respiratory Physician

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Dr. Arvindran A/L Alaga

Role: PRINCIPAL_INVESTIGATOR

Hospital Sultanah Bahiyah

Locations

Hospital Sultanah Bahiyah

Alor Star, Kedah, Malaysia

Site Status: RECRUITING

Countries

Malaysia

Central Contacts

Dr. Arvindran A/L Alaga

Role: CONTACT

arvindran_82@yahoo.com

+6047407395

LEDANG Coordinating Center

Role: CONTACT

clintrial.ledang@cancerresearch.my

+6047407395

Facility Contacts

Dr. Avindran A/L Alaga

Role: primary

arvindran_82@yahoo.com

+6047407395

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

NIH/800-3/2/2 Jilid 18 (38)

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

IIT-LEDANG2023001

Identifier Type: -

Identifier Source: org_study_id