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

Non-small Cell Lung Cancer Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05277844
• Other study ID #: 3338
• Secondary ID: CTRI/2019/11/021
• Status: Recruiting
• Phase: Phase 2
• Start date: November 11, 2019
• Est. completion date: November 11, 2025

Study information

• Verified date: April 2023
• Source: Tata Memorial Hospital
• Contact: Dr. Anil Tibdewal, MD
• Phone: 91-22-24177000
• Email: aniltibdewal[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 106
• Est. completion date: November 11, 2025
• Est. primary completion date: November 11, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer
• Oligometastatic Disease

Intervention

Radiation:
• Local Consolidative Radiation Therapy
Local consolidative radiation therapy to loco-regional disease and all Oligometastatic sites in addition to TKI

Drug:
• TKI
TKI

Locations

Country	Name	City	State
India	Tata Memorial Hospital	Mumbai	Maharashtra

Sponsors (1)

Lead Sponsor	Collaborator
Tata Memorial Hospital

Country where clinical trial is conducted

India, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Upto 2 years
Secondary	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).	Upto 2 years
Secondary	Health Related Quality of Life using the EORTC-QLQ-C30 questionnaire	Quality of life will be assessed for each arm	From time of randomization to time of death or up to 24 months
Secondary	Health Related Quality of Life using the EORTC-LC13 questionnaire	Quality of life will be assessed for each arm	From time of randomization to time of death or up to 24 months
Secondary	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	From time of Randomization to time of death or up to 24 months