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Recruiting NCT05277844

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

Phase II Interventional Oligometastatic Disease Non-small Cell Lung Cancer Driver Mutation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Local Consolidative Radiation Therapy, TKI.
Who it may be relevant to
Registry conditions: Oligometastatic Disease, Non-small Cell Lung Cancer, Driver Mutation. Basic parameters: 18 years — 99 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
India
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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

Interventions

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

Primary outcome measures

  • Progression Free Survival (PFS) [Time frame: Upto 2 years]
Secondary outcome measures (5)
  • Overall survival (OS) [Time frame: Upto 2 years]
  • Local control rates [Time frame: Upto 2 years]
  • Health Related Quality of Life using the EORTC-QLQ-C30 questionnaire [Time frame: From time of randomization to time of death or up to 24 months]
  • Health Related Quality of Life using the EORTC-LC13 questionnaire [Time frame: From time of randomization to time of death or up to 24 months]
  • Toxicities using CTC v5.0 (radiotherapy related) [Time frame: From time of Randomization to time of death or up to 24 months]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

India · 1 center
  • Tata Memorial Hospital — Mumbai

Publications

  • 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. PMID 33589450

Identifiers

NCT: NCT05277844 · 3338 · CTRI/2019/11/021872

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗