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

NCT ID: NCT05277844

Last Updated: 2025-09-10

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 106 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-11
• Study Completion Date: 2027-11-11

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.

Detailed Description

Randomization Arms: Eligible patients will be randomized in 1:1 ratio to TKI alone or TKI + LCRT. This will be an intention to treat randomized study.

Arm 1: Continuation of TKI therapy alone Arm 2: Continuation of TKI therapy + Local Consolidative Radiation therapy to loc0-regional disease and 1-5 oligometastatic sites

Conditions

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

Study Design

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

Study Groups

Arm 1: Continuation of TKI therapy alone

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

Group Type: ACTIVE_COMPARATOR

TKI

Intervention Type: DRUG

TKI

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

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

Group Type: EXPERIMENTAL

Local Consolidative Radiation Therapy

Intervention Type: RADIATION

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

TKI

Intervention Type: DRUG

TKI

Interventions

Local Consolidative Radiation Therapy

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

Intervention Type: RADIATION

TKI

TKI

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Patients with pathologically proven diagnosis of NSCLC

2. Patients with positive oncogene driver mutation (EGFR or ALK/ROS)

3. Patients who have received at least 2-4 months of TKI therapy without progression

4. 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)

5. Patients suitable for local consolidative therapy

6. 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);

7. Patients with ECOG performance status of 0-2

8. Age > 18 years

9. For females of child-bearing potential, negative serum or urine pregnancy test within 14 days prior to study registration

Exclusion Criteria

1. Patients with progressive disease after 2-3 months of initial TKI therapy

2. Patients with negative oncogene driver mutations (EGFR/ALK/ROS)

3. Patients not suitable for local consolidative radiation therapy

4. Patients who are not suitable for further continuation of TKI therapy due to toxicity

5. 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;

6. Patients with prior history of radiation therapy to thorax

7. Patients with second malignancy (Synchronous or Metachronous)

8. Pregnancy

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tata Memorial Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Anil Tibdewal

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dr. Anil Tibdewal, MD

Role: PRINCIPAL_INVESTIGATOR

Tata Memorial Hospital, Parel, Mumbai, Maharashtra, India

Locations

Tata Memorial Hospital

Mumbai, Maharashtra, India

Site Status: RECRUITING

Countries

India

Central Contacts

Dr. Anil Tibdewal, MD

Role: CONTACT

aniltibdewal@gmail.com

91-22-24177000 ext. 7030

Dr. Jai Prakash Agarwal, MD

Role: CONTACT

agarwaljp@tmc.gov.in

91-22-24177000 ext. 6791

Facility Contacts

Dr. Anil Tibdewal, MD

Role: primary

aniltibdewal@gmail.com

022-24177000 ext. 7030

References

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.

Reference Type: BACKGROUND

PMID: 33589450 (View on PubMed)

Other Identifiers

CTRI/2019/11/021872

Identifier Type: REGISTRY

Identifier Source: secondary_id

3338

Identifier Type: -

Identifier Source: org_study_id