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RecruitingNCT05278052TARGET-02Updated Sep 10, 2025

Standard Maintenance Therapy (SMT) vs Local Consolidative Radiation Therapy and SMT in OM-NSCLC

A Phase 3 interventional study of Local consolidative radiation therapy and Standard maintenance therapy as decided by the treating medical oncologist in Oligometastatic Disease and Metastatic Non Small Cell Lung Cancer, sponsored by Tata Memorial Hospital. Recruiting at 1 site in India. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2025-09-10.

Sponsored by Tata Memorial Hospital · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Apr 2026, 5 months ago, but the record still lists the study as recruiting.
  • Registered 1 year 10 months after the study started (first participant enrolled Apr 2020, registered Feb 2022).
  • Started Apr 2020; still recruiting 6 years 5 months later.
Phase
Phase 3
Study type
Interventional
Enrollment
190
Allocation
Randomized
Ages
18 Years to 99 Years
Sex
All
01

Study 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 the detailed description

Standard of care maintenance therapy alone (standard arm) versus local consolidative radiation therapy and standard of care maintenance therapy (Experimental arm)

02

Conditions studied

  • Oligometastatic Disease
  • Metastatic Non Small Cell Lung Cancer

Keywords

  • Local Consolidative Radiation Therapy
  • Oligometastatic disease
  • NSCLC
  • Maintenance therapy
  • SABR
03

In context

Carcinoma, Non-Small-Cell Lung

6,491 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,633 are open to participants now.

This study's planned enrollment of 190 is above the median of 62 across 5,216 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.

Browse Carcinoma, Non-Small-Cell Lung studies →

Lead sponsor

Tata Memorial Hospital is the lead sponsor of 97 studies on the registry; 20 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Age > 18 years
  2. Patients with ECOG performance status of 0-2
  3. Patients with pathologically proven diagnosis of NSCLC
  4. 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)
  5. Patients who have received standard duration of systemic therapy (4 - 6 cycles) without progression of the disease
  6. Patients suitable for definitive therapy to the primary disease
  7. 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.
  8. 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.
  9. 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.
  10. 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.
  11. 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);
  12. For females of child-bearing potential, negative serum or urine pregnancy test within 14 days prior to study registration;
  13. Patients willing for written informed consent and must be willing to comply with the specified follow up schedule

Exclusion criteria

Exclusion Criteria:

  1. Patients with progressive disease after initial standard systemic therapy
  2. Patients with oncogene driver mutations
  3. Patients with more than 5 sites of oligo metastases
  4. Patients with metastatic lesion size of more than 5 cm
  5. Patients with more than three metastatic lesion in one organ
  6. Patients not suitable for definitive radiation therapy to primary disease
  7. Patients not suitable for ablative radiation therapy to metastatic sites
  8. Patients with malignant peritoneal disease
  9. Patients with malignant pleural effusion
  10. Leptomeningeal disease
  11. Brain metastases in the brain stem
  12. Clinical or radiological evidence of spinal cord compression or metastases within 2 mm of spinal cord on MRI
  13. 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;
  14. Patients with prior history of radiation therapy to thorax
  15. Patients with previous history of malignancy within last 3 years from the date of diagnosis
  16. Pregnancy
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
190 participants (estimated)

Study arms

  • Active comparator
    ARM A: Standard maintenance therapy alone

    Maintenance systemic therapy/ observation

    Drug: Standard maintenance therapy as decided by the treating medical oncologist

  • Experimental
    ARM B: Local consolidative radiation therapy (LCRT)

    Radiation therapy to all oligometastatic sites including primary loco-regional disease

    Radiation: Local consolidative radiation therapy · Drug: Standard maintenance therapy as decided by the treating medical oncologist

Interventions

  • RadiationLocal consolidative radiation therapy

    Local consolidative radiation therapy (LCRT) to all oligo-metastatic sites in addition to primary disease site

    Also known as: LCRT

  • DrugStandard maintenance therapy as decided by the treating medical oncologist

    Standard maintenance therapy/Observation

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Upto 2 years

Secondary outcomes

  1. 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.

    Time frame: Upto 2 years

  2. Local control rates of treated sites

    Local control rate will be defined as the absence of progressive disease at the treated sites

    Time frame: Upto 2 years

  3. New distant metastases

    Time to onset of new distant metastases

    Time frame: Upto 2 years

  4. Health Related QOL using the EORTC-QLQ-C30 questionnaire

    To evaluate patient reported outcomes between the two arms

    Time frame: From randomization every 3 months till 2 years

  5. Health Related QOL using the EORTC- LC13 questionnaire

    To evaluate patient reported outcomes between the two arms

    Time frame: From randomization every 3 months till 2 years

  6. Response rates

    To compare response rates between the two arms

    Time frame: From randomization every 3 months upto 2 years

  7. Radiotherapy related toxicity using CTC v5.0 (radiotherapy related acute and late toxicity)

    At baseline and at subsequent follow up till 2 years

    Time frame: Upto 2 years

07

Study locations

1 of 1 sites recruiting
  • Tata Memorial Hospital, Parel
    Mumbai, Maharashtra 400012, India
    • Dr. Anil Tibdewal, MD · Contact · aniltibdewal@gmail.com · +91-22-24177000
    • Dr. Anil Tibdewal, MD · Principal investigator
    Recruiting
08

References and documents

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 ↗

Related links

Individual participant data

Plan to share: No — Protocol manuscript is published and the results will be published in International peer-reviewed journal

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 10, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05278052
Lead sponsor
Tata Memorial Hospital
Responsible party
Anil Tibdewal (Principal Investigator, Tata Memorial Hospital) — Principal investigator
First posted
Mar 14, 2022
Start date
Apr 20, 2020
Primary completion
Apr 20, 2026 (estimated)
Completion
Apr 20, 2028 (estimated)
Last update
Sep 10, 2025

Study contacts

Dr. Anil Tibdewal
Contact
aniltibdewal@gmail.com
+91-22-24177000 ext. 7030
Dr. Jai Prakash Agarwal
Contact
agarwaljp@tmc.gov.in
+91-22-24177000 ext. 6791
Dr. Anil Tibdewal
principal investigator · Tata Memorial Hospital, Parel, Mumbai, Maharashtra, India

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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