Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 1 / Phase 2INTERVENTIONAL

A Study of SHR-1826 for Injection in Combination With Other Antitumor Therapies in Subjects With NSCLC

A Multicenter, Open Phase IB/II Clinical Study of Safety, Tolerability, and Efficacy of SHR-1826 in Combination With Other Anti-cancer Treatment in Patients With Non-small Cell Lung Cancer

A Study of SHR-1826 for Injection in Combination With Other Antitumor Therapies in Subjects With NSCLC (NCT06754930) is a Phase 1 / Phase 2 interventional studying Non-small Cell Lung Cancer (NSCLC), sponsored by Suzhou Suncadia Biopharmaceuticals Co., Ltd.. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

This is an open label, multi-center, multiple dose Phase IB/II study to evaluate the safety, tolerability and efficacy of SHR-1826 for injection in subjects with NSCLC.

What Stage of Research Is This?

Phase 1 trials test a new treatment for the first time in humans, focusing on safety, dosing, and how the body processes the drug. For Non-small Cell Lung Cancer (NSCLC), a Phase 1 study typically enrolls a small number of participants — often healthy volunteers or patients who have exhausted standard treatment options. Phase 1 results determine whether a treatment moves into larger Phase 2 efficacy studies.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

A target enrollment of 400 participants makes this a sizable late-stage trial. Studies in this range typically have enough power to detect clinically meaningful differences from a comparator and to characterize less-common side effects.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Voluntary participation and written willing to sign a consent form. 2. 18-75 years older, no gender limitation. 3. Eastern Cooperative Oncology Group (ECOG) score: 0-1. 4. With a life expectancy ≥ 3 months. 5. Pathologically diagnosed NSCLC. 6. Be able to provide fresh or archived tumour tissue. 7. At least one measurable lesion according to RECIST v1.1. 8. your organs (liver, kidneys, etc.) are working well enough based on blood tests. 9. Contraception is required during clinical trials, and pregnancy tests must be negative for women of childbearing age within 7 days before the first dose. Who Should NOT Join This Trial: 1. Meningeal metastasis history or clinical symptoms of central nervous system metastasis. 2. Previous or co-existing malignancies. 3. Spinal cord compression that was not treated radically by surgery and/or radiotherapy was excluded. 4. Uncontrollable tumor-related pain. 5. Have undergone major surgery other than diagnosis or biopsy within 28 days prior to the initial dosing; Minor traumatic surgery within 7 days prior to the first dosing. 6. Received other investigational drugs treatments 4 weeks prior to the initiation of the study treatment. 7. Unresolved CTCAE 5.0\>grade 2 toxicities from previous anticancer therapy. 8. With poorly controlled or severe cardiovascular disease. 9. Active hepatitis B and hepatitis C. 10. Patients with a history of weakened immune system. 11. Severe infection 30 days before the first dose. Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: 1. Voluntary participation and written informed consent. 2. 18-75 years older, no gender limitation. 3. Eastern Cooperative Oncology Group (ECOG) score: 0-1. 4. With a life expectancy ≥ 3 months. 5. Pathologically diagnosed NSCLC. 6. Be able to provide fresh or archived tumour tissue. 7. At least one measurable lesion according to RECIST v1.1. 8. Adequate organ function. 9. Contraception is required during clinical trials, and pregnancy tests must be negative for women of childbearing age within 7 days before the first dose. Exclusion Criteria: 1. Meningeal metastasis history or clinical symptoms of central nervous system metastasis. 2. Previous or co-existing malignancies. 3. Spinal cord compression that was not treated radically by surgery and/or radiotherapy was excluded. 4. Uncontrollable tumor-related pain. 5. Have undergone major surgery other than diagnosis or biopsy within 28 days prior to the initial dosing; Minor traumatic surgery within 7 days prior to the first dosing. 6. Received other investigational drugs treatments 4 weeks prior to the initiation of the study treatment. 7. Unresolved CTCAE 5.0\>grade 2 toxicities from previous anticancer therapy. 8. With poorly controlled or severe cardiovascular disease. 9. Active hepatitis B and hepatitis C. 10. Patients with a history of immunodeficiency. 11. Severe infection 30 days before the first dose.

Treatments Being Tested

DRUG

SHR-1826

SHR-1826 for injection.

DRUG

SHR-1316

SHR-1316 for injection.

DRUG

SHR-9839

SHR-9839 for injection.

DRUG

SHR-8068

SHR-8068 for injection.

DRUG

Ametinib mesylate

Ametinib mesylate.

DRUG

BP-102

BP-102 for injection.

DRUG

Carboplatin

Carboplatin for injection.

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06754930), the sponsor (Suzhou Suncadia Biopharmaceuticals Co., Ltd.), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06754930 clinical trial studying?

This is an open label, multi-center, multiple dose Phase IB/II study to evaluate the safety, tolerability and efficacy of SHR-1826 for injection in subjects with NSCLC. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06754930?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06754930?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06754930. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06754930. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.