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

Tata Memorial Hospital

Status and phase: Enrolling; Phase 2

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

Treatments: Radiation: Local Consolidative Radiation Therapy; Drug: TKI

Study type: Interventional

Funder types: Other

Identifiers

NCT05277844

3338

CTRI/2019/11/021872 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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

Enrollment: 106 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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106 participants in 2 patient groups

Arm 1: Continuation of TKI therapy alone

Active Comparator group

Description:

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

Treatment:

Drug: TKI

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

Experimental group

Description:

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

Treatment:

Drug: TKI

Radiation: Local Consolidative Radiation Therapy