About this trial
This is an open-label, multi-cohort, multicenter Phase Ib/II clinical study designed to evaluate the safety, tolerability, and efficacy of SYS6090 injection in combination with chemotherapy or chemotherapy and bevacizumab or SYS6010 (an EGFR ADC) in participants with advanced lung cancer.
Eligibility criteria
Qualifiers
Voluntarily signed written informed consent.
Age 18 to 75 years at the time of informed consent, with no restriction on sex.
Histologically or cytologically confirmed unresectable locally advanced (stage IIIB/IIIC) or metastatic (stage IV) non-small cell lung cancer (NSCLC) according to the AJCC/UICC Cancer Staging System, 8th edition, or extensive-stage small cell lung cancer (SCLC), not amenable to curative surgical resection or definitive chemoradiotherapy.
At least one measurable lesion according to RECIST v1.1.
Disqualifiers
Use of systemic corticosteroids or other immunosuppressive therapies within 14 days prior to the first dose of study treatment, except for physiologic replacement doses or permitted local, inhaled, or prophylactic use.
Unresolved > Grade 1 toxicities related to prior anticancer therapy (except for toxicities judged by the investigator to pose no safety risk).
For Cohorts 5A and 5B: prior permanent discontinuation of EGFR-targeted therapy due to dermatologic toxicity, or presence of dermatologic diseases requiring systemic treatment.
Known active central nervous system metastases or leptomeningeal metastases, except for stable and adequately treated brain metastases without the need for ongoing corticosteroids or antiepileptic therapy.
Trial design
Treatments tested in this trial
- SYS6090 + pemetrexed + platinum-based chemotherapy
- SYS6090 + paclitaxel + platinum-based chemotherapy
- SYS6090 + docetaxel
- SYS6090 + pemetrexed + bevacizumab + platinum-based chemotherapy
- SYS6090 + SYS6010
- SYS6090 + etoposide + platinum-based chemotherapy
- SYS6090 + chemotherapy or other anticancer therapy
Treatment groups
8
Treatment groupsSee each treatment group below.