Local Consolidative Radiation Therapy Plus TKI Versus TKI Alone in Driver Mutated OM-NSCLC

NCT05277844 | Recruiting Phase 2 DMC

• 2 other identifiers: 3338CTRI/2019/11/021872
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

Brief Summary

A Phase II randomized controlled trial of TKI Alone versus TKI and Local Consolidative Radiation Therapy in oncogene driver mutated oligo metastatic Non-small cell lung cancer patients.

Conditions

Oligometastatic Disease; Non-small Cell Lung Cancer; Driver Mutation

Keywords

Oligometastatic NSCLC; Driver mutation; TKI; Local consolidative therapy; SABR; Oligometastases

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival (PFS)

  Progression Free Survival will be defined as the time from the date of randomization until the date of disease recurrence or progression is documented, or until death in the absence of recurrence, whichever is earlier.

  Upto 2 years

Secondary Outcomes (5)

• Overall survival (OS)

  Upto 2 years

• Local control rates

  Upto 2 years

• Health Related Quality of Life using the EORTC-QLQ-C30 questionnaire

  From time of randomization to time of death or up to 24 months

• Health Related Quality of Life using the EORTC-LC13 questionnaire

  From time of randomization to time of death or up to 24 months

• Toxicities using CTC v5.0 (radiotherapy related)

  From time of Randomization to time of death or up to 24 months

Study Arms (2)

Arm 1: Continuation of TKI therapy alone

ACTIVE COMPARATOR

Patients in this arm will continue to receive standard treatment of TKI alone

Drug: TKI

Arm 2: Continuation of TKI therapy + Local Consolidative Radiation therapy to 1-5 sites

EXPERIMENTAL

Patients will receive local consolidate radiation therapy to all oligo-metastatic sites plus radiation therapy to primary disease in addition to TKI

Radiation: Local Consolidative Radiation Therapy; Drug: TKI

Interventions

Local Consolidative Radiation Therapy RADIATION

Local consolidative radiation therapy to loco-regional disease and all Oligometastatic sites in addition to TKI

Arm 2: Continuation of TKI therapy + Local Consolidative Radiation therapy to 1-5 sites

TKI DRUG

TKI

Arm 1: Continuation of TKI therapy alone; Arm 2: Continuation of TKI therapy + Local Consolidative Radiation therapy to 1-5 sites

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with pathologically proven diagnosis of NSCLC
• Patients with positive oncogene driver mutation (EGFR or ALK/ROS)
• Patients who have received at least 2-4 months of TKI therapy without progression
• Patients with 1-5 sites of metastatic disease not including the primary tumor and regional nodes (less than 3 metastatic lesions in one organ will be eligible and 4 or more metastatic lesions in one organ will be ineligible)
• Patients suitable for local consolidative therapy
• Adequate end-organ function CBC/differential obtained within 15 days prior to registration on study, with adequate bone marrow function defined as follows:
• Absolute neutrophil count (ANC) ≥ 500 cells/mm3;
• Platelets ≥ 50,000 cells/mm3;
• Hemoglobin ≥ 8.0 g/dl (Use of transfusion or other intervention to achieve Hgb ≥ 8.0 g/dl is acceptable);
• Patients with ECOG performance status of 0-2
• Age \> 18 years
• For females of child-bearing potential, negative serum or urine pregnancy test within 14 days prior to study registration

You may not qualify if:

• Patients with progressive disease after 2-3 months of initial TKI therapy
• Patients with negative oncogene driver mutations (EGFR/ALK/ROS)
• Patients not suitable for local consolidative radiation therapy
• Patients who are not suitable for further continuation of TKI therapy due to toxicity
• Severe, active co-morbidity defined as follows:
• Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months;
• Transmural myocardial infarction within the last 6 months;
• Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration;
• Patients with prior history of radiation therapy to thorax
• Patients with second malignancy (Synchronous or Metachronous)
• Pregnancy

Sponsors & Collaborators

• Tata Memorial Hospital: lead

Study Sites (1)

Tata Memorial Hospital

Mumbai, Maharashtra, 400012, India

RECRUITING

Related Publications (1)

• Tibdewal A, Agarwal J, Mummudi N, Noronha V, Prabhash K, Patil V, Purandare N, Janu A, Kaushal R, Kannan S. Protocol for a phase II randomised controlled trial of TKI alone versus TKI and local consolidative radiation therapy in patients with oncogene driver-mutated oligometastatic non-small cell lung cancer. BMJ Open. 2021 Feb 15;11(2):e041345. doi: 10.1136/bmjopen-2020-041345.

  PMID: 33589450 BACKGROUND

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Dr. Anil Tibdewal, MD

  Tata Memorial Hospital, Parel, Mumbai, Maharashtra, India

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr. Anil Tibdewal, MD

CONTACT

91-22-24177000; aniltibdewal@gmail.com

Dr. Jai Prakash Agarwal, MD

CONTACT

91-22-24177000; agarwaljp@tmc.gov.in

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: Open-label, parallel-group RCT

Study Record Dates

• First Submitted: February 22, 2022
• First Posted: March 14, 2022
• Study Start: November 11, 2019
• Primary Completion (Estimated): November 11, 2026
• Study Completion (Estimated): November 11, 2027
• Last Updated: September 10, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)