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

ConditionsOligometastatic DiseaseNon-small Cell Lung CancerDriver Mutation
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-99
SponsorTata Memorial Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Local Consolidative Radiation Therapy

    Radiation

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

  • TKI

    Drug

    TKI

Treatment groups

106 Participants
are divided into 2 treatment groups
Group A: Arm 1: Continuation of TKI therapy aloneActive comparator 1 intervention
Group B: Arm 2: Continuation of TKI therapy + Local Consolidative Radiation therapy to 1-5 sitesExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
Upto 2 years

Secondary outcomes

1

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.

Time frame
Upto 2 years
2

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).

Time frame
Upto 2 years
3

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

Quality of life will be assessed for each arm

Time frame
From time of randomization to time of death or up to 24 months
4

Health Related Quality of Life using the EORTC-LC13 questionnaire

Quality of life will be assessed for each arm

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Tata Memorial Hospital

Lead sponsor

Source ClinicalTrials.gov
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