Study on Ipatasertib and Docetaxel for Metastatic Non-Small Cell Lung Cancer Patients After First-Line Immunotherapy

Sponsor: Jun Zhang, MD, PhD

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04467801

Provider View

This clinical trial is exploring a new treatment combination of ipatasertib and docetaxel for patients with metastatic non-small cell lung cancer (NSCLC) who have not responded to initial immunotherapy. The study aims to find out if this combination can be more effective for these patients.

Patient Parameters

Program Overview

This study is for patients with advanced non-small cell lung cancer (NSCLC) who have not benefited from the first round of immunotherapy. The standard treatment for these patients often includes immunotherapy alone or with chemotherapy, but not all patients respond well. This trial is testing a new combination of drugs, ipatasertib and docetaxel, to see if it can help these patients. Ipatasertib is a drug that targets a specific protein in cancer cells, and it may enhance the effects of chemotherapy and immunotherapy.

Eligibility Criteria

Inclusion Criteria

  • Must understand the study and be willing to sign a consent form.
  • Expected to live at least 12 more weeks.
  • Must be 18 years or older.
  • Must have previously received first-line immunotherapy, either alone or with chemotherapy.
  • Must have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
  • Must have measurable cancer according to specific criteria.
  • Must have advanced or metastatic NSCLC and have not responded to or cannot tolerate first-line immunotherapy.
  • Must have adequate organ function.
  • Women who can become pregnant and men with partners who can become pregnant must agree to use effective birth control during the study and for 90 days after.
  • Men must agree not to donate sperm during the study and for 90 days after.

Exclusion Criteria

  • Cannot be enrolled in another clinical study unless it is observational.
  • Cannot use other investigational drugs within 14 days before and during the study.
  • Cannot have mixed small cell and non-small cell lung cancer.
  • Cannot have unresolved severe side effects from previous immunotherapy.
  • Cannot have mutations that qualify for targeted therapy.
  • Cannot be on other cancer treatments 14 days before starting the study, except for certain local therapies.
  • Cannot use certain medications that affect drug metabolism.
  • Cannot have had major surgery within 4 weeks before the study.
  • Cannot have uncontrolled systemic disease or brain metastasis.
  • Cannot have a history of allergy to taxanes.
  • Cannot have certain heart conditions or active infections.
  • Cannot have conditions affecting drug absorption or the ability to swallow pills.
  • Cannot have uncontrolled diabetes or high cholesterol.
  • Cannot have certain bowel diseases or lung conditions.
  • Cannot have uncontrolled fluid buildup in the body.
  • Cannot have psychiatric or social issues affecting study participation.
  • Cannot be pregnant, breastfeeding, or planning to become pregnant during the study or for 90 days after.
  • Men with partners who can become pregnant cannot plan to father a child or donate sperm during the study or for 90 days after.
  • Cannot have any condition that might interfere with the study or patient safety.

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