NCT05236946 Observation or Upfront Cranial RT in Oncogene Mutated NSCLC With Asymptomatic BM: A Phase III RCT
| NCT ID | NCT05236946 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Tata Memorial Hospital |
| Condition | Asymptomatic Brain Metastases |
| Study Type | INTERVENTIONAL |
| Enrollment | 190 participants |
| Start Date | 2020-11-10 |
| Primary Completion | 2025-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 190 participants in total. It began in 2020-11-10 with a primary completion date of 2025-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Tyrosine Kinase Inhibitors (TKIs) especially higher generation TKI have higher CNS penetration rates and have shown favorable response rates in brain metastases. Brain radiotherapy/surgery is the standard treatment in brain metastases especially symptomatic metastases, however, the role of local treatment especially in driver mutation-positive non-small cell lung cancer with asymptomatic brain metastases is being questioned given their potential side effects. No randomized trial has shown the superiority of early vs delayed cranial RT in asymptomatic BM of driver mutated NSCLC.
Eligibility Criteria
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 positive oncogene mutation status (EGFR/ALK) 5. Patients with radiologically confirmed parenchymal brain metastases 6. Patients with asymptomatic Synchronous or Metachronous brain metastases 7. Patients willing for written informed consent and must be willing to comply with the specified follow-up schedule Exclusion Criteria: 1. Patients with CSF dissemination only without any parenchymal brain metastases 2. Patients with brain metastases in the brain stem 3. Patients with prior history of radiation therapy to the brain 4. Patient not suitable for TKI therapy as per the medical oncologist 5. Pregnant or lactating females
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05236946 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 99 Years, studying Asymptomatic Brain Metastases. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05236946 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 190 participants.
Is NCT05236946 currently recruiting?
Yes, NCT05236946 is actively recruiting participants. Contact the research team at aniltibdewal@gmail.com for enrollment information.
Where is the NCT05236946 trial being conducted?
This trial is being conducted at Mumbai, India.
Who is sponsoring the NCT05236946 clinical trial?
NCT05236946 is sponsored by Tata Memorial Hospital. The trial plans to enroll 190 participants.