Oligometastatic DiseasePhase 2TARGET-01NCT05277844
Local Consolidative Radiation Therapy Plus TKI Versus TKI Alone in Driver Mutated OM-NSCLC
A Phase 2 study testing Local Consolidative Radiation Therapy and TKI in people with Oligometastatic Disease and Non-small Cell Lung Cancer, run by Tata Memorial Hospital at 1 site in India.
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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Oligometastatic Disease, Non-small Cell Lung Cancer, Driver Mutation
- What is being tested?
- Local Consolidative Radiation Therapy and TKI
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteIndia
- Study dates
- 11 Nov 2019to 11 Nov 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- 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
Who cannot join
- 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;
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
India1 site, 1 recruiting
- Recruiting
Tata Memorial Hospital
Mumbai, Maharashtra, 400012
Dr. Anil Tibdewal, MD, 022-24177000 ext. 7030, aniltibdewal@gmail.com
Dr. Anil Tibdewal, MD
About this study
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
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.
Read the 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
- Being tested
- Local Consolidative Radiation Therapy, TKI
- Keywords
- Oligometastatic NSCLC, Driver mutation, TKI, Local consolidative therapy, SABR, Oligometastases
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Local Consolidative Radiation TherapyRadiation
Local consolidative radiation therapy to loco-regional disease and all Oligometastatic sites in addition to TKI
TKIDrug
TKI
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Continuation of TKI therapy alone | Active comparator | Patients in this arm will continue to receive standard treatment of TKI alone Receives: Drug: TKI |
| Arm 2: Continuation of TKI therapy + Local Consolidative Radiation therapy to 1-5 sites | Experimental | Patients will receive local consolidate radiation therapy to all oligo-metastatic sites plus radiation therapy to primary disease in addition to TKI Receives: Radiation: Local Consolidative Radiation Therapy; Drug: TKI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Upto 2 years
Secondary outcomes (5)
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.
Measured: Upto 2 years
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).
Measured: Upto 2 years
Health Related Quality of Life using the EORTC-QLQ-C30 questionnaire
Quality of life will be assessed for each arm
Measured: From time of randomization to time of death or up to 24 months
Health Related Quality of Life using the EORTC-LC13 questionnaire
Quality of life will be assessed for each arm
Measured: From time of randomization to time of death or up to 24 months
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
Measured: From time of Randomization to time of death or up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2022
- Study start11 Nov 2019
- Primary completion11 Nov 2026 (estimated)
- Study completion11 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Oligometastatic DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Open-label, parallel-group RCT
- Masking
- None (open label)
- Enrolment
- 106 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tata Memorial Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Anil Tibdewal, Tata Memorial Hospital
- Investigators
- Dr. Anil Tibdewal, MD, Principal investigator, Tata Memorial Hospital, Parel, Mumbai, Maharashtra, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05277844
- Sponsor's protocol ID
- 3338
- Other IDs
- CTRI/2019/11/021872
- Acronym
- TARGET-01
- Status last verified
- Sep 2025
- First submitted
- 22 Feb 2022
- Last updated
- 10 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Protocol manuscript is published and the results will be published in International peer-reviewed journal
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.
PubMed 33589450
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05277844
- Acronym / sponsor ID
- TARGET-01 / 3338
- Keywords
- Oligometastatic NSCLC, Driver mutation, TKI, Local consolidative therapy, SABR, Oligometastases
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 106 participants (estimated)
- Lead sponsor
- Tata Memorial HospitalOther government
- Study start
- 11 Nov 2019 (actual)
- Primary completion
- 11 Nov 2026 (estimated)
- Study completion
- 11 Nov 2027 (estimated)
- First posted
- 14 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Open-label, parallel-group RCT
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Continuation of TKI therapy alone | Active comparator | Drug: TKIPatients in this arm will continue to receive standard treatment of TKI alone |
| Arm 2: Continuation of TKI therapy + Local Consolidative Radiation therapy to 1-5 sites | Experimental | Radiation: Local Consolidative Radiation Therapy, Drug: TKIPatients will receive local consolidate radiation therapy to all oligo-metastatic sites plus radiation therapy to primary disease in addition to TKI |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (11 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Local Consolidative Radiation TherapyLocal consolidative radiation therapy to loco-regional disease and all Oligometastatic sites in addition to TKI | Radiation | Arm 2: Continuation of TKI therapy + Local Consolidative Radiation therapy to 1-5 sites |
| TKITKI | Drug | Arm 1: Continuation of TKI therapy alone, Arm 2: Continuation of TKI therapy + Local Consolidative Radiation therapy to 1-5 sites |
Primary outcome
Progression Free Survival (PFS)
Time frame: Upto 2 years
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.
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2025.
- Background: PubMed 33589450Tibdewal 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.
- Individual participant dataSharing planned: No. Protocol manuscript is published and the results will be published in International peer-reviewed journal
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dr. Anil Tibdewal, MD principal investigator
Tata Memorial Hospital, Parel, Mumbai, Maharashtra, India
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Local Consolidative Radiation Therapy and TKI in people with Oligometastatic Disease and Non-small Cell Lung Cancer, run by Tata Memorial Hospital at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr. Anil Tibdewal, MD (91-22-24177000 ext. 7030, aniltibdewal@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression Free Survival (PFS) (time frame: Upto 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05277844, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2025.