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RecruitingPhase 2

A Study to Evaluate the Efficacy and Safety of Sutetinib Maleate Capsule in Locally Advanced or Metastatic NSCLC

A Multicenter, Open-label, Phase 2 Study to Evaluate the Efficacy and Safety of Sutetinib Maleate Capsule in Locally Advanced or Metastatic NSCLC (Uncommon EGFR Mutations Only)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how well sutetinib maleate capsules work and how safe they are. It is for adults with non-small cell lung cancer that has spread nearby or to other parts of the body and has an uncommon change in the EGFR gene.

The main objective of the study will be to evaluate the efficacy of sutetinib maleate capsules in participants with locally advanced or metastatic non-small cell lung cancer NSCLC (uncommon EGFR mutations only).

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are age 18 or older.
  • Tests of tissue or cells confirm non-small cell lung cancer that has spread nearby or to other parts of the body.
  • A tumor tissue sample shows an uncommon change in the EGFR gene.
  • You have at least one tumor that can be measured.
  • Your activity score (ECOG) is 0, 1, or 2: you can care for yourself and are out of bed for at least half the day.
  • You are expected to live more than 3 months.
  • Your bone marrow makes enough blood cells, and your liver, kidneys, and blood clotting work well enough.
  • Other entry rules also apply.

Who can't join

  • You previously took an EGFR-blocking cancer drug (EGFR TKI). For group 1, any such drug rules you out; for group 2, this applies to second-generation drugs.
  • You had certain recent cancer treatments: chemotherapy or certain radiation within 3 weeks; immunotherapy within 4 weeks; or symptom-relief radiation to non-target tumors or tumor-directed Chinese medicines within 2 weeks. Group 2 also has a waiting period after EGFR drugs.
  • You recently used drugs or foods that strongly affect CYP3A4, a protein that breaks down drugs. The waiting period is at least 14 days and may be longer.
  • You had major-organ surgery, other than a needle biopsy, or a serious injury within 4 weeks.
  • You still have side effects from past treatment that are more than mild, except hair loss.
  • You cannot swallow the capsules, or you have a severe long-term stomach or bowel problem or another condition that affects how your body absorbs medicine.
  • You have active cancer spread to the brain or spinal cord, or an active infection that is not controlled at screening.
  • Other rules for who cannot join also apply.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: 1. Age 18 years old and above, male or female 2. Histopathological and/or cytopathological confirmation of locally advanced or metastatic NSCLC 3. Confirmation that the tumor harbors an uncommon epidermal growth factor receptor (EGFR) mutation (tumor tissue biopsy) 4. At least one measurable lesion 5. Eastern Cooperative Oncology Group (ECOG) score of 0, 1, or 2 6. A minimum life expectancy of \> 3 months 7. Adequate bone marrow reserve, hepatic, renal, and coagulation function Other inclusion criteria apply for participating in the study. Exclusion Criteria: 1. Participant ever used the epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR TKI) for anti-tumor therapy prior to enrollment (Cohort 1), or second generation EGFR TKI (Cohort 2) 2. Any systemic anti-tumor therapy such as chemotherapy and radiation therapy (including curative radiotherapy or spinal radiotherapy portion \>30%) used within 3 weeks prior to enrollment; immunotherapy within 4 weeks; any palliative radiotherapy for non-target lesions used to relieve symptoms and traditional Chinese medicines indicated for the tumor within 2 weeks prior to enrollment; Cohort 2: any EGFR TKIs within 5 half-lives. 3. Use or intake of drugs or foods containing potent inhibitors or inducers of cytochrome P450 isozyme 3A4 (CYP3A4) within 14 days or 5 half-lives, whichever is the longer, prior to enrollment 4. Surgical operation (excluding aspiration biopsy) of main organs or a significant injury within 4 weeks prior to enrollment 5. Any unresolved toxicities from prior therapy greater than National Cancer Institute-Common Terminology Criteria for Adverse Events Version 5.0 (NCI-CTCAEv5.0) Grade 1, at the time of screening except for alopecia 6. Inability to swallow the study medication, any seriously (NCI-CTCAEv5.0 ≥ Grade 3) chronic gastrointestinal disorder, malabsorption syndrome or any other conditions with influence on gastrointestinal absorption 7. Active central nervous system metastases 8. Any active infection which has not been controlled at screening Other exclusion criteria apply for participating in the Study.

Study sites (9)

CA

FL

GA

IA

KY

NY

TX