Oligometastatic DiseasePhase 3TARGET-02NCT05278052
Standard Maintenance Therapy (SMT) vs Local Consolidative Radiation Therapy and SMT in OM-NSCLC
A Phase 3 study testing Local consolidative radiation therapy and Standard maintenance therapy as decided by the treating medical oncologist in people with Oligometastatic Disease and Metastatic Non Small Cell Lung Cancer, run by Tata Memorial Hospital at 1 site in India.
Trial summary
Standard Maintenance Therapy versus Local Consolidative Radiation Therapy and standard maintenance therapy in 1-5 sites of OligoMetastatic Non-small cell lung cancer (NSCLC): A Phase III Randomized Controlled Trial Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Oligometastatic Disease, Metastatic Non Small Cell Lung Cancer
- What is being tested?
- Local consolidative radiation therapy and Standard maintenance therapy as decided by the treating medical oncologist
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 190 participants
- Where
- 1 siteIndia
- Study dates
- 20 Apr 2020to 20 Apr 2028
- Phase
- Phase 3
- 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
- Age > 18 years
- Patients with ECOG performance status of 0-2
- Patients with pathologically proven diagnosis of NSCLC
- Patients with 1-5 sites of metastatic disease not including the primary tumor and regional nodes (less than or equal to 3 metastatic lesions in one organ will be eligible and 4 or more metastatic lesions in one organ will be ineligible)
- Patients who have received standard duration of systemic therapy (4 - 6 cycles) without progression of the disease
- Patients suitable for definitive therapy to the primary disease
Show all 16Show fewer
- All the Oligometastases lesions should be radiologically visible and suitable for ablative doses of radiation in accordance with the dose fractionation regimens specified in the protocol.
- Patients who have received ablative radiation therapy or surgery or RFA for metastatic sites at presentation or during systemic therapy will be eligible provided the total number of oligometastatic sites at the time of study entry (treated site included) is less than or equal to five.
- Patients who have received palliative RT for symptomatic bony metastases or RFA will also be eligible provided the treated site is under control on imaging. If not controlled, could be eligible for study if further ablative doses of radiation can be delivered according to the treating physician.
- Patients who underwent surgical decompression, or stabilization followed by palliative radiation therapy for bony metastases will be eligible in the study provided the treated site is under control on imaging and patient has less than 5 sites of metastases at the time of study entry.
- 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);
- For females of child-bearing potential, negative serum or urine pregnancy test within 14 days prior to study registration;
- Patients willing for written informed consent and must be willing to comply with the specified follow up schedule
Who cannot join
- Patients with progressive disease after initial standard systemic therapy
- Patients with oncogene driver mutations
- Patients with more than 5 sites of oligo metastases
- Patients with metastatic lesion size of more than 5 cm
- Patients with more than three metastatic lesion in one organ
- Patients not suitable for definitive radiation therapy to primary disease
Show all 19Show fewer
- Patients not suitable for ablative radiation therapy to metastatic sites
- Patients with malignant peritoneal disease
- Patients with malignant pleural effusion
- Leptomeningeal disease
- Brain metastases in the brain stem
- Clinical or radiological evidence of spinal cord compression or metastases within 2 mm of spinal cord on MRI
- 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 previous history of malignancy within last 3 years from the date of diagnosis
- 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, Parel
Mumbai, Maharashtra, 400012
Dr. Anil Tibdewal, MD, +91-22-24177000 ext. 7030, aniltibdewal@gmail.com
Dr. Anil Tibdewal, MD
About this study
Official title: Standard Maintenance Therapy Versus Local Consolidative Radiation Therapy and Standard Maintenance Therapy in 1-5 Sites of Oligometastatic Non-small Cell Lung Cancer (NSCLC): A Phase III Randomized Controlled Trial
Standard Maintenance Therapy versus Local Consolidative Radiation Therapy and standard maintenance therapy in 1-5 sites of OligoMetastatic Non-small cell lung cancer (NSCLC): A Phase III Randomized Controlled Trial
Read the detailed description
Standard of care maintenance therapy alone (standard arm) versus local consolidative radiation therapy and standard of care maintenance therapy (Experimental arm)
- Being tested
- Local consolidative radiation therapy, Standard maintenance therapy as decided by the treating medical oncologist
- Keywords
- Local Consolidative Radiation Therapy, Oligometastatic disease, NSCLC, Maintenance therapy, SABR
- 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
Also called LCRT
Local consolidative radiation therapy (LCRT) to all oligo-metastatic sites in addition to primary disease site
Standard maintenance therapy as decided by the treating medical oncologistDrug
Standard maintenance therapy/Observation
| Study group | Role | What they receive |
|---|---|---|
| ARM A: Standard maintenance therapy alone | Active comparator | Maintenance systemic therapy/ observation Receives: Drug: Standard maintenance therapy as decided by the treating medical oncologist |
| ARM B: Local consolidative radiation therapy (LCRT) | Experimental | Radiation therapy to all oligometastatic sites including primary loco-regional disease Receives: Radiation: Local consolidative radiation therapy; Drug: Standard maintenance therapy as decided by the treating medical oncologist |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival (OS)
Overall survival is defined as the duration between the date of randomization to the date of death due to any cause or the date of last follow-up, whichever is earlier.
Measured: Upto 2 years
Secondary outcomes (7)
Progression free survival (PFS )
Progression free survival is defined as the duration between the date of randomization to the date of first documented progression or death due to any cause or date of last follow-up, whichever is earlier.
Measured: Upto 2 years
Local control rates of treated sites
Local control rate will be defined as the absence of progressive disease at the treated sites
Measured: Upto 2 years
New distant metastases
Time to onset of new distant metastases
Measured: Upto 2 years
Health Related QOL using the EORTC-QLQ-C30 questionnaire
To evaluate patient reported outcomes between the two arms
Measured: From randomization every 3 months till 2 years
Health Related QOL using the EORTC- LC13 questionnaire
To evaluate patient reported outcomes between the two arms
Measured: From randomization every 3 months till 2 years
Response rates
To compare response rates between the two arms
Measured: From randomization every 3 months upto 2 years
Radiotherapy related toxicity using CTC v5.0 (radiotherapy related acute and late toxicity)
At baseline and at subsequent follow up till 2 years
Measured: Upto 2 years
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 start20 Apr 2020
- Primary completion20 Apr 2026 (estimated)
- Study completion20 Apr 2028 (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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Phase III, Open-label, Randomized controlled trial,
- Masking
- None (open label)
- Enrolment
- 190 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, Principal investigator, Tata Memorial Hospital, Parel, Mumbai, Maharashtra, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05278052
- Sponsor's protocol ID
- 3445
- Other IDs
- CTRI/2020/04/024761
- Acronym
- TARGET-02
- 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 JP, Srinivasan S, Mummudi N, Noronha V, Prabhash K, Patil V, Purandare N, Janu A, Kannan S. Standard maintenance therapy versus local consolidative radiation therapy and standard maintenance therapy in 1-5 sites of oligometastatic non-small cell lung cancer: a study protocol of phase III randomised controlled trial. BMJ Open. 2021 Mar 16;11(3):e043628. doi: 10.1136/bmjopen-2020-043628.
PubMed 33727268
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
- Standard Maintenance Therapy Versus Local Consolidative Radiation Therapy and Standard Maintenance Therapy in 1-5 Sites of Oligometastatic Non-small Cell Lung Cancer (NSCLC): A Phase III Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05278052
- Acronym / sponsor ID
- TARGET-02 / 3445
- Keywords
- Local Consolidative Radiation Therapy, Oligometastatic disease, NSCLC, Maintenance therapy, SABR
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 190 participants (estimated)
- Lead sponsor
- Tata Memorial HospitalOther government
- Study start
- 20 Apr 2020 (actual)
- Primary completion
- 20 Apr 2026 (estimated)
- Study completion
- 20 Apr 2028 (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.
Standard Maintenance Therapy versus Local Consolidative Radiation Therapy and standard maintenance therapy in 1-5 sites of OligoMetastatic Non-small cell lung cancer (NSCLC): A Phase III Randomized Controlled Trial
Detailed description
Standard of care maintenance therapy alone (standard arm) versus local consolidative radiation therapy and standard of care maintenance therapy (Experimental arm)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Phase III, Open-label, Randomized controlled trial,
| Arm | Type | Receives |
|---|---|---|
| ARM A: Standard maintenance therapy alone | Active comparator | Drug: Standard maintenance therapy as decided by the treating medical oncologistMaintenance systemic therapy/ observation |
| ARM B: Local consolidative radiation therapy (LCRT) | Experimental | Radiation: Local consolidative radiation therapy, Drug: Standard maintenance therapy as decided by the treating medical oncologistRadiation therapy to all oligometastatic sites including primary loco-regional disease |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Age > 18 years
- Patients with ECOG performance status of 0-2
- Patients with pathologically proven diagnosis of NSCLC
- Patients with 1-5 sites of metastatic disease not including the primary tumor and regional nodes (less than or equal to 3 metastatic lesions in one organ will be eligible and 4 or more metastatic lesions in one organ will be ineligible)
- Patients who have received standard duration of systemic therapy (4 - 6 cycles) without progression of the disease
Key exclusion criteria (19 listed)
- Patients with progressive disease after initial standard systemic therapy
- Patients with oncogene driver mutations
- Patients with more than 5 sites of oligo metastases
- Patients with metastatic lesion size of more than 5 cm
- Patients with more than three metastatic lesion in one organ
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 therapyAlso: LCRTLocal consolidative radiation therapy (LCRT) to all oligo-metastatic sites in addition to primary disease site | Radiation | ARM B: Local consolidative radiation therapy (LCRT) |
| Standard maintenance therapy as decided by the treating medical oncologistStandard maintenance therapy/Observation | Drug | ARM A: Standard maintenance therapy alone, ARM B: Local consolidative radiation therapy (LCRT) |
Primary outcome
Overall survival (OS)
Time frame: Upto 2 years
Overall survival is defined as the duration between the date of randomization to the date of death due to any cause or the date of last follow-up, whichever is earlier.
7 secondary outcomes
Progression free survival (PFS )
Time frame: Upto 2 years
Local control rates of treated sites
Time frame: Upto 2 years
New distant metastases
Time frame: Upto 2 years
Health Related QOL using the EORTC-QLQ-C30 questionnaire
Time frame: From randomization every 3 months till 2 years
Health Related QOL using the EORTC- LC13 questionnaire
Time frame: From randomization every 3 months till 2 years
Response rates
Time frame: From randomization every 3 months upto 2 years
Radiotherapy related toxicity using CTC v5.0 (radiotherapy related acute and late toxicity)
Time frame: Upto 2 years
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 33727268Tibdewal A, Agarwal JP, Srinivasan S, Mummudi N, Noronha V, Prabhash K, Patil V, Purandare N, Janu A, Kannan S. Standard maintenance therapy versus local consolidative radiation therapy and standard maintenance therapy in 1-5 sites of oligometastatic non-small cell lung cancer: a study protocol of phase III randomised controlled trial. BMJ Open. 2021 Mar 16;11(3):e043628. doi: 10.1136/bmjopen-2020-043628.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. Protocol manuscript is published and the results will be published in International peer-reviewed journal
Related trials for Oligometastatic Disease
Active, not recruitingPhase 2/3
Veterans Affairs Seamless Phase II/III Randomized Trial of STAndard Systemic theRapy With or Without PET-directed Local Therapy for Oligometastatic pRosTate Cancer
Prostate Cancer, Oligometastasis
RecruitingEarly Phase 1
Real-Time Atherosclerosis Activity After Thoracic Radiotherapy Using Sodium Fluoride Positron Emission Tomography
Oligometastatic Disease
RecruitingPhase 2
Testing the Addition of Total Ablative Therapy to Usual Systemic Therapy Treatment for Limited Metastatic Colorectal Cancer, ERASur Trial
Metastatic Colorectal Adenocarcinoma, Stage IV Colorectal Cancer AJCC v8
Not yet recruitingPhase 2
Serplulimab, DOS and Lenvatinib Combine With PIPAC in the Oligometastatic Peritoneal Metastasis of Gastric/Gastroesophageal Junction Adenocarcinoma
Gastric/Gastroesophageal Junction Adenocarcinoma, Oligometastatic Peritoneal Metastasis
Not yet recruitingPhase 2
Stereotactic Body Radiation Therapy (SBRT) and Immunotherapy for Oligometastatic Esophageal Cancer
Esophageal Cancer
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 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 3 study testing Local consolidative radiation therapy and Standard maintenance therapy as decided by the treating medical oncologist in people with Oligometastatic Disease and Metastatic 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 16 inclusion and 19 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 (+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?
Overall survival (OS) (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 NCT05278052, 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.