Back to Lung Cancer
NCT03753685
NCT03753685
Who may be able to join
Who might be able to join this trial:
- Your lung cancer (non-small cell type) has been confirmed by a lab test and has a specific gene change called an ALK mutation.
- You have brain metastases (cancer that has spread to the brain) confirmed by a scan, with at least one measurable area that has not previously been treated with radiation therapy.
- You have had at most one round of chemotherapy, which was finished at least 4 weeks before starting this trial, and any side effects from it have gone away.
- You are 18 years of age or older.
- You are well enough to carry out some daily activities, as measured by a standard health scoring system (confirm with trial site).
- Your doctors expect you to live for at least 12 weeks.
- Your blood counts, liver, and kidney function are within acceptable levels as determined by blood tests (confirm with trial site).
- Any side effects from previous treatment have reduced to a mild level, except for hair loss.
- You are willing and able to attend appointments, follow the treatment plan, and complete required tests.
- You have read, understood, and signed the consent form for the trial.
Who may not be able to join:
- You are currently receiving another cancer treatment.
- You have had another active cancer within the last 5 years.
- You have participated in another clinical trial within the last 4 weeks.
- You have had surgery or immunotherapy within the last 4 weeks, or radiation therapy within the last 2 weeks.
- You have previously had an organ transplant or stem cell transplant.
- You have significant heart or blood vessel disease (confirm with trial site).
- You have difficulty swallowing, active digestive problems, or other conditions that may affect how your body absorbs the study medication.
- You are an active carrier of hepatitis B, hepatitis C, syphilis, or HIV.
- You have a history of, or currently show signs of, a lung scarring condition called interstitial lung disease.
- You are pregnant or breastfeeding.
- You have a known allergy or sensitivity to the study drug or its ingredients.
- You are currently taking or have taken within the last 14 days certain medications that can affect heart rhythm or interfere with how the study drug is processed by the body (confirm with trial site).
- You are currently taking warfarin or similar blood-thinning medications.
- You have other health conditions that might interfere with the study treatment (confirm with trial site).
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Trial details
Status
Active, Not Recruiting
Phase
Phase 2
Sponsor
Fudan University
Registry
clinicaltrials_gov
Start date
12 April 2019
Est. completion
30 June 2025
Where this trial is recruiting
🇨🇳 China
Primary endpoints
Intracranial objective response rate (iORR) based on investigator assessment according to RNAO-BM.
Can't join this trial?
Data last synced from ClinicalTrials.gov: 30 June 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.