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Ceritinib + Docetaxel for Lung Cancer
Study Summary
This trial is testing the combination of two drugs, ceritinib and docetaxel, to see if it is effective and safe for people with NSCLC.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
Media Library
- I am fully active or restricted in physically strenuous activity but can do light work.If you had brain metastases before, you can join if: they were treated, you don't have symptoms, you stopped taking corticosteroids for them at least 7 days ago, they are not getting worse, and you meet other health requirements. If you can become pregnant, you must use birth control.I am allergic to ceritinib, docetaxel, or their ingredients.I haven't had major surgery in the last 4 weeks or still have side effects.I have NSCLC and no other active cancers, except possibly skin cancer.I have severe side effects from cancer treatment, except for hair loss.I haven't taken any cancer drugs within the last 2 weeks.I had severe side effects from previous taxane therapy.I do not have recent severe heart problems.I am willing and able to follow the study's schedule and procedures.My lung cancer is at an advanced stage (IIIB/IV).I am not taking any medication that affects heart rhythm or interacts with ceritinib.I've had 1-3 treatments for advanced cancer, including one with platinum and possibly one with PD-1/PD-L1 inhibitors.I can provide a recent biopsy sample or, if not possible, an older sample with approval.My cancer has ALK rearrangements.I have GI issues that could affect medication absorption or I can't swallow pills.My cancer has EGFR mutations.I am 18 years old or older.Your diabetes is not well controlled, and your fasting blood sugar level is higher than 200 mg/dL.I have had a serious lung condition not caused by an infection that affected my daily activities or needed treatment.I have had radiation before but have recovered from the side effects.
- Group 1: Phase I Dose Escalation
- Group 2: Phase Ib Dose Expansion
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Are there any precedents of Docetaxel being studied in other research?
"As of now, 375 clinical trials are exploring the potentials benefits of Docetaxel. Of those experiments, 131 have entered Phase 3 and take place in 29502 distinct sites worldwide with Fuzhou, Fujian being host to a majority of them."
Are there still openings for volunteers in this research endeavor?
"As listed on clinicaltrials.gov, this research effort has been recruiting patients since February 1st 2019 and the details have most recently been updated at the end of September 2022."
Has Docetaxel been greenlit by the FDA?
"Docetaxel's safety rating is 1 due to the limited pre-existing data regarding its efficacy and safety, as this trial marks Phase 1."
What is the aggregate population size of individuals participating in this clinical trial?
"Affirmative. Clinicaltrials.gov provides evidence that this investigation, which was initially posted on February 1st 2019, is currently seeking participants. This study demands 48 patients from 2 separate sites."
In what contexts is Docetaxel typically prescribed?
"Docetaxel is typically prescribed for amino acid supplementation, but has also seen success in treating brca1 gene mutations, neoplasm metastasis and metastatic bladder cancer."
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