Back to results

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

Primary Purpose

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

Status

Recruiting

Phase

Phase 2

Locations

India

Study Type

Interventional

Intervention

Local Consolidative Radiation Therapy

TKI

About this trial

This is an interventional treatment trial for Oligometastatic Disease focused on measuring Oligometastatic NSCLC, Driver mutation, TKI, Local consolidative therapy, SABR, Oligometastases

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept 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;
Patients with prior history of radiation therapy to thorax
Patients with second malignancy (Synchronous or Metachronous)
Pregnancy

Sites / Locations

Tata Memorial HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Arm 1: Continuation of TKI therapy alone

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

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Overall survival (OS)

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

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

Quality of life will be assessed for each arm

Health Related Quality of Life using the EORTC-LC13 questionnaire

Quality of life will be assessed for each arm

Toxicities using CTC v5.0 (radiotherapy related)

Toxicity will be defined as per the common terminology criteria version 5.0 at baseline and at subsequent follow up till 2 years

Full Information

NCT ID

NCT05277844

First Posted

February 22, 2022

Last Updated

April 11, 2023

Sponsor

Tata Memorial Hospital

1. Study Identification

Unique Protocol Identification Number

NCT05277844

Brief Title

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

Acronym

TARGET-01

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Recruiting

Study Start Date

November 11, 2019 (Actual)

Primary Completion Date

November 11, 2023 (Anticipated)

Study Completion Date

November 11, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Tata Memorial Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. 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.

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Model Description

Open-label, parallel-group RCT

Masking

None (Open Label)

Allocation

Randomized

Enrollment

106 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm 1: Continuation of TKI therapy alone

Arm Type

Active Comparator

Arm Description

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

Arm Title

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

Arm Type

Experimental

Arm Description

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

Intervention Type

Radiation

Intervention Name(s)

Local Consolidative Radiation Therapy

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

TKI

Intervention Description

TKI

Primary Outcome Measure Information:

Title

Progression Free Survival (PFS)

Description

Time Frame

Upto 2 years

Secondary Outcome Measure Information:

Title

Overall survival (OS)

Description

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.

Time Frame

Upto 2 years

Title

Local control rates

Description

Local control will be defined as the lack of progressive disease at the treated sites (complete response, partial response and stable disease).

Time Frame

Upto 2 years

Title

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

Description

Quality of life will be assessed for each arm

Time Frame

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

Title

Health Related Quality of Life using the EORTC-LC13 questionnaire

Description

Quality of life will be assessed for each arm

Time Frame

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

Title

Toxicities using CTC v5.0 (radiotherapy related)

Description

Toxicity will be defined as per the common terminology criteria version 5.0 at baseline and at subsequent follow up till 2 years

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

99 Years

Accepts Healthy Volunteers

Eligibility Criteria

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; Patients with prior history of radiation therapy to thorax Patients with second malignancy (Synchronous or Metachronous) Pregnancy

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Dr. Anil Tibdewal, MD

Phone

91-22-24177000

Ext

7030

aniltibdewal@gmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

Dr. Jai Prakash Agarwal, MD

Phone

91-22-24177000

Ext

6791

agarwaljp@tmc.gov.in

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Dr. Anil Tibdewal, MD

Organizational Affiliation

Tata Memorial Hospital, Parel, Mumbai, Maharashtra, India

Official's Role

Principal Investigator

Facility Information:

Facility Name

Tata Memorial Hospital

City

Mumbai

State/Province

Maharashtra

ZIP/Postal Code

400012

Country

India

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Dr. Anil Tibdewal, MD

Phone

022-24177000

Ext

7030

aniltibdewal@gmail.com

First Name & Middle Initial & Last Name & Degree

Dr. Anil Tibdewal, MD

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

Protocol manuscript is published and the results will be published in International peer-reviewed journal

Citations:

PubMed Identifier

33589450

Citation

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.

Results Reference

background

Learn more about this trial

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

We'll reach out to this number within 24 hrs