A Study on Low dose immunotherapy in combination with standard dose chemotherapy in patients with Non-small cell carcinoma having central lesions

A Study on Low -dose Nivolumab combined with Platinum-Based Doublet Chemotherapy in Patients with Central Squamous Non-Small Cell Lung Cancer: Phase II, Single Arm, Single Centre Study - NIL

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/04/085141

Enrollment

Registered

2025-04-21

Start date

Unknown

Completion date

Unknown

Last updated

2025-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: J984- Other disorders of lung

Interventions

Intervention1: IMMUNOTHERAPY: Low dose Nivolumab Nivolumab at a dose of 20mg every thrice weekly in combination with standard dose platinum based doublet chemotherapy Control Intervention1: Not appli

Eligibility

Inclusion criteria

Inclusion criteria: 18 years and above patients diagnosed to have central non-small cell lung cancer

Exclusion criteria

Exclusion criteria: 1) Prior exposure to any anti-PD-1 or anti-PD-L1 antibody 2) Previous or ongoing treatment (any chemotherapy, therapeutic radiotherapy, or immunotherapy) for Squamous NSCLC Note: Palliative radiotherapy is allowed 3) Participation in another clinical study with an investigational product during the last 3 months

Design outcomes

Primary

Measure	Time frame
progression free survivalTimepoint: progression free survival assessed every 3 weekly	—

Secondary

Measure	Time frame
overall responseTimepoint: Response rate will be cumulative percentage of subjects having complete response & partial response as best response which will be assessed in accordance with RECIST version 1.1 criteria assessed every 6 weekly;overall survivalTimepoint: Overall survival will be defined as time duration from date of randomization until occurrence of death. Subjects who have not died will be censored at the time they were last known to be alive. Kaplan Meier method will be used for estimation assessed at every 3 weekly;quality of lifeTimepoint: Quality of life according to EQ-5D & EORTC QLQ-ELD14 questionnaires every 6 weeks: Quality of Life will be analyzed descriptively & according to the scoring manual. Absolute & relative variation compared to randomization time point will be calculated by patient assessed every 6 weekly	—

Measure

Time frame

overall responseTimepoint: Response rate will be cumulative percentage of subjects having complete response & partial response as best response which will be assessed in accordance with RECIST version 1.1 criteria assessed every 6 weekly;overall survivalTimepoint: Overall survival will be defined as time duration from date of randomization until occurrence of death. Subjects who have not died will be censored at the time they were last known to be alive. Kaplan Meier method will be used for estimation assessed at every 3 weekly;quality of lifeTimepoint: Quality of life according to EQ-5D & EORTC QLQ-ELD14 questionnaires every 6 weeks: Quality of Life will be analyzed descriptively & according to the scoring manual. Absolute & relative variation compared to randomization time point will be calculated by patient assessed every 6 weekly

—

Countries

India

Contacts

Public ContactDr Pawan Kumar SIngh

Pandit B.D Sharma, PGIMS, Rohtak

pawansingh.pgims@uhsr.ac.in8437013094

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026