A Trial of SHR-A2102 With Adebrelimab With or Without Other Antitumor Therapy in Advanced or Metastatic Non-small Cell Lung Cancer

Recruitment & Eligibility

Status: RECRUITING

Sex: All

Target Recruitment: 248

Inclusion Criteria

Have the ability to give informed consent, have signed informed and able to comply with the treatment plan to visit the tests and other procedural requirements；
The age of signing the informed consent is 18 -70 years, regardless of gender；
Provide archived or fresh tumor tissue for vendor test;
At least one measurable lesion according to RECIST v1.1 criteria；
Subjects with pathology confirmed locally advanced unresectable or metastatic non-small cell lung squamous cell carcinoma;
The ECOG score is 0 or 1；
Expected survival ≥12 weeks
Good level of organ function
Male subjects whose partners are women of childbearing age and female subjects who are fertile are required to use highly effective contraceptive methods.

Exclusion Criteria

Active or symptomatic brain metastases.
With the exception of patients diagnosed with any other malignancy, except those who have achieved complete remission at least 5 years prior to screening and have ended adjuvant therapy, can be treated locally and have a clear medical record of cure, such as basal cell or squamous cell carcinoma of the skin, superficial bladder cancer in situ, carcinoma in situ of the cervix, breast ductal carcinoma in situ, and papillary carcinoma of the thyroid.
Moderate or severe ascites with clinical symptoms, unable to control or moderate or above pleural effusion and pericardial effusion.
Patients with uncontrolled tumor-related pain .
Have antitumor therapy was received 4 weeks before the start of the study.
Perform non-chest radiation therapy with >30Gy within 28 days before dosing, chest radiation therapy with >30Gy within 24 weeks before first dosing, and radiation therapy with ≤30Gy within 14 days before first dosing.
Subjects who are participating in another clinical study or whose first dose is less than 4 weeks from the end of the previous clinical study (last dose), or the 5 half-life of the investigational drug, whichever is shorter.
Surgical procedures requiring tracheal intubation and general anesthesia were performed within 28 days prior to the initial study, diagnostic or superficial surgery was performed within 7 days prior to the initial study, or elective surgery was expected during the trial period.
Toxicity and/or complications of previous antitumor therapy did not return to NCI-CTCAE level ≤1 or exclusion criteria
Systemic immunosuppressive therapy was administered within 14 days prior to the first study.
Subjects with a prior history of interstitial pneumonia/non-infectious pneumonia requiring hormone therapy, and currently known or suspected interstitial pneumonia/non-infectious pneumonia.
The presence of any active, known or suspected autoimmune disease.
Subjects with severe cardiovascular and cerebrovascular diseases.
Subjects who had a severe infection within 28 days prior to the first dose
Active hepatitis B or active hepatitis C.
Patients with active pulmonary tuberculosis within 1 year prior to enrolment.
Clinically significant bleeding symptoms or significant bleeding tendency occurred within 1 month before the first medication
History of immune deficiency
Live attenuated vaccines were used within 28 days prior to initial study administration or during the expected study treatment；
Female subjects who are pregnant or plan to become pregnant during the study period.
Uncontrollable mental illness and other conditions known to affect the completion of the study process, such as alcohol, drug or substance abuse, and criminal detention.
Per the investigator's judgment, there are any other circumstances that may increase the risk of participating in the study, interfere with the study results, or make participation in the study inappropriate.

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment group A	SHR-A2102；Adebrelimab；Cisplatin/ Carboplatin	SHR-A2102+Adebrelimab+Cisplatin/ Carboplatin

Primary Outcome Measures

Name	Time	Method
RP2D	through phase IB completion, an average of 1 years	RP2D will be determined on the basis of evaluation on safety, PK, efficacy data in Phase IB stages；
Incidence and severity of AE(DLT)	from Day1 to 90 days after last dose	According to NCI-CTCAE v5.0 evaluation criteria from Day 1 to 90 days after last dose；
ORR	18 months after the last subject was enrolled in the group	efficacy was assessed every 6 weeks within 48 weeks and every 9 weeks after 48 weeks s as determined by RECIST1.1

Secondary Outcome Measures

Name	Time	Method
DCR	18 months after the last subject was enrolled in the group	Since C1D1 every 6 weeks within 48 weeks and every 9 weeks after 48 weeks, and the proportion of subjects whose best response was PR or CR or SD as determined by RECIST1.1；
DOR	18 months after the last subject was enrolled in the group	Since C1D1 every 6 weeks within 48 weeks and every 9 weeks after 48 weeks, and the proportion of subjects whose best response was PR or CR or SD as determined by RECIST1.1；
OS(Investigator evaluation)	18 months after the last subject was enrolled in the group	Since C1D1 and death from any cause；
PFS(Investigator evaluation)	18 months after the last subject was enrolled in the group	Since C1D1 every 6 weeks within 48 weeks and every 9 weeks after 48 weeks, and the proportion of subjects whose best response was PR or CR or SD as determined by RECIST1.1；

A Trial of SHR-A2102 With Adebrelimab With or Without Other Antitumor Therapy in Advanced or Metastatic Non-small Cell Lung Cancer

Recruitment & Eligibility

Study & Design

Trial Locations

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