Non-Small Cell Carcinoma of LungPhase 2NCT07882940
Becotatug Vedotin + Pucotenlimab+Platinum Induction and Sequential CCRT for Unresectable LA NSCLC
A Phase 2 study testing Becotatug Vedotin (MRG003)+pucotenlimab+platinum and radiotherapy in people with Non-Small Cell Carcinoma of Lung and Locally Advanced, run by Sun Yat-sen University.
Trial summary
This is a prospective, single-arm phase II clinical study enrolling patients with locally advanced unresectable non-small cell lung cancer. All enrolled patients receive induction therapy with Becotatug Vedotin combined with pucotenlimab and platinum-based regimens. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Non-Small Cell Carcinoma of Lung, Locally Advanced
- What is being tested?
- Becotatug Vedotin (MRG003)+pucotenlimab+platinum and radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- 15 Nov 2026to 31 Oct 2031
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged from 18 to 70 years old;
- Subjects must be histopathologically diagnosed with non-small cell lung cancer originating from the bronchus or lung;
- Clinically confirmed as locally advanced unresectable stage IIIA, IIIB, or IIIC non-small cell lung cancer according to the 9th edition of the AJCC Cancer Staging System;
- ECOG performance status score of 0-1;
- Adequate organ and bone marrow function (without blood transfusion or hematopoietic stimulating factor medication within 14 days before evaluation):
- Blood routine: absolute neutrophil count ≥1.5×10⁹/L, platelet count ≥100×10⁹/L, hemoglobin ≥9.0 g/dL; Liver function: total bilirubin ≤1.5×ULN; ALT/AST ≤2.5×ULN; Renal function: serum creatinine ≤1.5×ULN, or creatinine clearance rate ≥40 mL/min (calculated by the Cockcroft-Gault formula); Adequate cardiac function with left ventricular ejection fraction (LVEF) >50% detected by echocardiography;
- Capable of signing the informed consent form (ICF) and complying with all requirements and restrictions specified in the ICF and study protocol;
- Able to receive regular follow-up with good treatment compliance.
Who cannot join
- Patients with EGFR-sensitive mutations (L858R, 19Del) or ALK/ROS1/RET gene fusions;
- Patients who have received any anti-tumor treatment prior to the initiation of this trial;
- Pregnant or lactating women;
- Patients with a history of allergy to any of the following drugs: pucotenlimab, Becotatug Vedotin, platinum agents, taxanes, etoposide, and pemetrexed;
- Patients with a history of other malignant tumors within the past 5 years or with concurrent malignant tumors;
- Patients with uncontrolled clinical cardiac symptoms or diseases, including:
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- Heart failure of NYHA class II or above;
- Unstable angina;
- Myocardial infarction occurred within 1 year prior to enrollment;
- Clinically significant supraventricular or ventricular arrhythmia requiring clinical intervention;
- Patients who have received any of the following treatments:
- Administration of any investigational drugs before the first dose of study drug;
- Concurrent enrollment in another clinical study, except for observational (non-interventional) clinical studies or the follow-up phase of interventional clinical studies;
- Systemic treatment with corticosteroids (daily dose equivalent to more than 10 mg prednisone) or other immunosuppressants within 2 weeks before the first dose of study drug. Topical corticosteroids for local inflammation, allergy prevention or anti-emetic treatment are permitted. In the absence of active autoimmune diseases, inhaled or topical steroids and adrenal corticosteroid replacement therapy at a dose equivalent to more than 10 mg prednisone daily are allowed;
- Vaccination with anti-tumor vaccines or live vaccines within 4 weeks before the first dose of study drug;
- Major surgery or severe trauma within 4 weeks before the first dose of study drug;
- Patients with severe infection (CTCAE grade ≥2) within 4 weeks before the first dose of study drug, such as severe pneumonia requiring hospitalization, bacteremia, and infectious complications. Patients with active pulmonary inflammation indicated by baseline chest imaging, or with infectious signs and symptoms requiring oral or intravenous antibiotic therapy within 2 weeks before the first dose of study drug (prophylactic antibiotic use is excluded);
- Patients with active autoimmune diseases (including but not limited to interstitial pneumonia, colitis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, and hypothyroidism). Patients with vitiligo or resolved childhood asthma/allergy without any intervention in adulthood are excluded from this criterion;
- Patients with a history of immune deficiency diseases, including HIV-positive status, other acquired or congenital immune deficiency diseases, or a history of organ or bone marrow transplantation;
- Patients with active pulmonary tuberculosis infection confirmed by medical history or CT examination, or with a history of active pulmonary tuberculosis infection within 1 year before enrollment, or with a previous history of active pulmonary tuberculosis infection more than 1 year prior that has not received standardized treatment;
- Patients with active hepatitis: HBV DNA ≥2000 IU/mL (or 10,000 copies/mL); or positive hepatitis C antibody with HCV-RNA level above the detection limit of the analytical method;
- Patients with a history of psychoactive drug abuse, alcoholism or drug addiction;
- Patients who are unable to understand or likely to fail to comply with the trial requirements;
- Patients deemed unsuitable for enrollment by the investigators.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Becotatug Vedotin Combined With Pucotenlimab and Platinum Induction Therapy Followed by Concurrent Chemoradiotherapy for Locally Advanced Unresectable NSCLC: a Prospective, Single-arm Phase II Trial
This is a prospective, single-arm phase II clinical study enrolling patients with locally advanced unresectable non-small cell lung cancer. All enrolled patients receive induction therapy with Becotatug Vedotin combined with pucotenlimab and platinum-based regimens. Patients who complete the scheduled induction treatment will subsequently receive definitive concurrent chemoradiotherapy.
- Conditions
- Non-Small Cell Carcinoma of Lung, Locally Advanced
- Being tested
- Becotatug Vedotin (MRG003)+pucotenlimab+platinum, radiotherapy
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Becotatug Vedotin (MRG003)+pucotenlimab+platinumDrug
Becotatug Vedotin 2.0 mg/kg on day 1 every 3 weeks plus pucotenlimab 200 mg on day 1 every 3 weeks, combined with cisplatin 25 mg/m² on days 1-3 or carboplatin at an AUC of 5 on day 1 every 3 weeks, for a total of 2 cycles.
radiotherapyRadiation
Concurrent chemoradiotherapy (taxane plus platinum regimen is administered during concurrent radiotherapy). Intensity modulated radiotherapy is adopted with a prescribed dose of 54-66 Gy using conventional fractionation.
| Study group | Role | What they receive |
|---|---|---|
| Study arm | Experimental | ADC+ICIs+chemotherapy+radiotherapy Receives: Drug: Becotatug Vedotin (MRG003)+pucotenlimab+platinum; Radiation: radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR)
The proportion of patients whose tumor volume is reduced to a predefined threshold (CR+PR) and maintained for a minimum required duration.
Measured: Efficacy evaluation after concurrent chemoradiotherapy at 1 month.
Secondary outcomes (3)
Progression-Free Survival (PFS)
The time from the initiation of induction therapy to the first confirmed disease progression or death.
Measured: From enrollment to the end of treatment at 3 years
Overall survival (OS)
Time from the initiation of induction therapy to death.
Measured: From enrollment to the end of treatment at 5 years
Adverse Events
Any untoward and unintended medical occurrence, including abnormal laboratory findings, symptoms, or diseases.
Measured: From enrollment to the end of treatment at 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2026
- Study start15 Nov 2026 (estimated)
- Primary completion31 Oct 2029 (estimated)
- Study completion31 Oct 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Small Cell Carcinoma of LungStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cai Ling, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07882940
- Sponsor's protocol ID
- B2026-553-01
- Status last verified
- Oct 2026
- First submitted
- 5 Oct 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Becotatug Vedotin Combined With Pucotenlimab and Platinum Induction Therapy Followed by Concurrent Chemoradiotherapy for Locally Advanced Unresectable NSCLC: a Prospective, Single-arm Phase II Trial
- ClinicalTrials.gov ID
- NCT07882940
- Acronym / sponsor ID
- B2026-553-01
- Conditions
- Non-Small Cell Carcinoma of Lung, Locally Advanced
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 15 Nov 2026 (estimated)
- Primary completion
- 31 Oct 2029 (estimated)
- Study completion
- 31 Oct 2031 (estimated)
- First posted
- 20 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective, single-arm phase II clinical study enrolling patients with locally advanced unresectable non-small cell lung cancer. All enrolled patients receive induction therapy with Becotatug Vedotin combined with pucotenlimab and platinum-based regimens. Patients who complete the scheduled induction treatment will subsequently receive definitive concurrent chemoradiotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study arm | Experimental | Drug: Becotatug Vedotin (MRG003)+pucotenlimab+platinum, Radiation: radiotherapyADC+ICIs+chemotherapy+radiotherapy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Aged from 18 to 70 years old;
- Subjects must be histopathologically diagnosed with non-small cell lung cancer originating from the bronchus or lung;
- Clinically confirmed as locally advanced unresectable stage IIIA, IIIB, or IIIC non-small cell lung cancer according to the 9th edition of the AJCC Cancer Staging System;
- ECOG performance status score of 0-1;
- Adequate organ and bone marrow function (without blood transfusion or hematopoietic stimulating factor medication within 14 days before evaluation):
Key exclusion criteria (24 listed)
- Patients with EGFR-sensitive mutations (L858R, 19Del) or ALK/ROS1/RET gene fusions;
- Patients who have received any anti-tumor treatment prior to the initiation of this trial;
- Pregnant or lactating women;
- Patients with a history of allergy to any of the following drugs: pucotenlimab, Becotatug Vedotin, platinum agents, taxanes, etoposide, and pemetrexed;
- Patients with a history of other malignant tumors within the past 5 years or with concurrent malignant tumors;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Becotatug Vedotin (MRG003)+pucotenlimab+platinumBecotatug Vedotin 2.0 mg/kg on day 1 every 3 weeks plus pucotenlimab 200 mg on day 1 every 3 weeks, combined with cisplatin 25 mg/m² on days 1-3 or carboplatin at an AUC of 5 on day 1 every 3 weeks, for a total of 2 cycles. | Drug | Study arm |
| radiotherapyConcurrent chemoradiotherapy (taxane plus platinum regimen is administered during concurrent radiotherapy). Intensity modulated radiotherapy is adopted with a prescribed dose of 54-66 Gy using conventional fractionation. | Radiation | Study arm |
Primary outcome
Objective response rate (ORR)
Time frame: Efficacy evaluation after concurrent chemoradiotherapy at 1 month.
The proportion of patients whose tumor volume is reduced to a predefined threshold (CR+PR) and maintained for a minimum required duration.
3 secondary outcomes
Progression-Free Survival (PFS)
Time frame: From enrollment to the end of treatment at 3 years
Overall survival (OS)
Time frame: From enrollment to the end of treatment at 5 years
Adverse Events
Time frame: From enrollment to the end of treatment at 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Becotatug Vedotin (MRG003)+pucotenlimab+platinum and radiotherapy in people with Non-Small Cell Carcinoma of Lung and Locally Advanced, run by Sun Yat-sen University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ling Cai, Dr. (+86 02087343417, cailing@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (ORR) (time frame: Efficacy evaluation after concurrent chemoradiotherapy at 1 month.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.