TARGET-01: Local Consolidative Radiation Therapy Plus TKI Versus TKI Alone in Driver Mutated OM-NSCLC

Sponsor

Tata Memorial Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05277844

Collaborator

(none)

106

Enrollment

Location

Arms

Anticipated Duration (Months)

1.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Oligometastatic Disease Non-small Cell Lung Cancer Driver Mutation	Radiation: Local Consolidative Radiation Therapy Drug: TKI	Phase 2

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

106 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Open-label, parallel-group RCTOpen-label, parallel-group RCT

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Nov 11, 2019

Anticipated Primary Completion Date :

Nov 11, 2023

Anticipated Study Completion Date :

Nov 11, 2025

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Arm 1: Continuation of TKI therapy alone Patients in this arm will continue to receive standard treatment of TKI alone	Drug: TKI TKI
Experimental: 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	Radiation: Local Consolidative Radiation Therapy Local consolidative radiation therapy to loco-regional disease and all Oligometastatic sites in addition to TKI Drug: TKI TKI

Arm

Intervention/Treatment

Active Comparator: Arm 1: Continuation of TKI therapy alone

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

Drug: TKI

TKI

Experimental: 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

Radiation: Local Consolidative Radiation Therapy

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

Drug: TKI

TKI

Outcome Measures

Primary Outcome Measures

Progression Free Survival (PFS) [Upto 2 years]
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.

Secondary Outcome Measures

Overall survival (OS) [Upto 2 years]
Overall survival will be defined as the time from randomization until the date of death from any cause in the presence or absence of recurrence.
Local control rates [Upto 2 years]
Local control will be defined as the lack of progressive disease at the treated sites (complete response, partial response and stable disease).
Health Related Quality of Life using the EORTC-QLQ-C30 questionnaire [From time of randomization to time of death or up to 24 months]
Quality of life will be assessed for each arm
Health Related Quality of Life using the EORTC-LC13 questionnaire [From time of randomization to time of death or up to 24 months]
Quality of life will be assessed for each arm
Toxicities using CTC v5.0 (radiotherapy related) [From time of Randomization to time of death or up to 24 months]
Toxicity will be defined as per the common terminology criteria version 5.0 at baseline and at subsequent follow up till 2 years

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 99 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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;