HS-10504 vs platinum-based chemotherapy in EGFR C797S+ NSCLC

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized, open-label, multicenter Phase III trial evaluating HS-10504 monotherapy against a platinum-based doublet (pemetrexed with cisplatin or carboplatin) in adults with locally advanced or metastatic NSCLC harboring the EGFR C797S mutation after failure of EGFR TKI therapy. Eligible participants have at least one measurable lesion and adequate organ function. Exclusion criteria include other driver mutations, recent major toxicities, prior another primary cancer, and significant cardiac issues. The study aims to determine whether HS-10504 can provide comparable or improved efficacy with a manageable safety profile versus standard chemotherapy. Primary endpoints typically include radiographic response and progression-free survival, with safety monitored throughout.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age ≥18 years.
2. Histologically or cytologically confirmed locally advanced or metastatic NSCLC (Stage IIIB, IIIC, or IV).
3. Documented failure after ≥1 prior line of EGFR TKI therapy with concurrent C797S mutation.
4. At least one measurable target lesion per RECIST v1.1 criteria.

Exclusion Criteria:

1. Presence of other well-documented driver gene mutations (e.g., ALK fusion, ROS1 fusion, KRAS activating mutations, MET exon 14 skipping, HER2 mutations, RET fusion).
2. Histological or phenotypic transformation (e.g., NSCLC to SCLC transformation, epithelial-to-mesenchymal transition) confirmed by tumor tissue obtained within 6 months prior to first dose.
3. ≥ Grade 2 toxicities (per CTCAE v6.0) attributed to prior anti-tumor therapy (excluding alopecia and stable neurotoxicity).
4. History of other primary malignancies.
5. Inadequate bone marrow reserve or hepatic/renal organ function.
6. Clinically significant cardiac abnormalities or severe/uncontrolled/active cardiovascular disease.
7. Poorly controlled diabetes mellitus or hypertension.
8. Significant clinical bleeding tendency or history of severe arterial/venous thromboembolic events.
9. Severe or uncontrolled active infection.
10. Continuous systemic corticosteroid therapy (\>30 days) within 30 days prior to first dose, or requirement for long-term (≥30 days) corticosteroid use.
11. Active infectious diseases (e.g., active hepatitis B virus \[HBV\] infection).
12. Clinically significant gastrointestinal disorders.
13. Hepatic encephalopathy, hepatorenal syndrome, or cirrhosis ≥ Child-Pugh class B.
14. Other pulmonary diseases that may interfere with assessment or management of drug-related pneumotoxicity.
15. History of severe neurological or psychiatric disorders.

Where it's running

• Guangzhou Medical University
  Guangzhou, China Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.