Lung Cancer Stage IIIPhase 2NIBCUNNCT03872661
Neoadjuvant IBI308, Bevacizumab, Plus Pemetrexed and Carboplatin Followed by Surgery in Unresectable Stage III NSCLC
A Phase 2 study testing IBI308, Bevacizumab and Pemetrexed in people with Lung Cancer Stage III, run by Sun Yat-sen University at 1 site in China.
Trial summary
The purpose of this study is to studying neoadjuvant IBI308, bevacizumab, plus pemetrexed and carboplatin followed by surgery to see how well it works in treating patients with unresectable stage III non-small cell lung cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Lung Cancer Stage III
- What is being tested?
- IBI308, Bevacizumab and Pemetrexed
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2019to 31 Dec 2029
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Target population is unresectable stage III non-small cell lung cancer.
- Written informed consent provided.
- Subjects should not have a previously detected sensitizing EGFR mutation or ALK fusion oncogene.
- Male and female patients aged ≥18 years, < 75 years.
- Able to comply with the required protocol and follow-up procedures, and able to receive oral medications.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
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- Life expectancy ≥12 weeks.
- Adequate hematological function: Absolute neutrophil count (ANC) ≥2.0 x 109/L, and Platelet count ≥100 x 109/L, and Hemoglobin ≥9 g/dL (may be transfused to maintain or exceed this level).
- Adequate liver function: Total bilirubin ≤ 1.5 x upper limit of normal (ULN), Aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤ 2.5 x ULN in subjects without liver metastases; ≤ 5 x ULN in subjects with liver metastases.
- Adequate renal function: Serum creatinine ≤ 1.25 x ULN, or ≥ 60 ml/min.
- Female subjects should not be pregnant or breast-feeding.
Who cannot join
- Known severe hypersensitivity to IBI308 or any of the excipients of this product.
- Prior therapy with anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibody (including any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways).
- Prior chemotherapy or radiotherapy.
- Subjects with active, known or suspected autoimmune disease. Subjects in conditions not expected to recur in the absence of an external trigger, or not requiring systemic treatment are permitted to enroll.
- Subjects with a condition requiring systemic treatment with either corticosteroids (>10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of first administration of study treatment. Inhaled or topical steroids, and adrenal replacement steroid doses > 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease.
- Inability to comply with protocol or study procedures.
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- A serious concomitant systemic disorder that, in the opinion of the investigator, would compromise the patient's ability to complete the study.
- A serious cardiac condition, such as myocardial infarction within 6 months, angina, or heart disease.
- History of another malignancy in the last 5 years with the exception of the following: other malignancies cured by surgery alone and having a continuous disease-free interval of 5 years are permitted. Cured basal cell carcinoma of the skin and cured in situ carcinoma of the uterine cervix are permitted.
- Any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction within the previous year, serious cardiac arrhythmia requiring medication, hepatic, renal, or metabolic disease).
- Patient who has active serious infection (e.g. pyrexia of or 38.0℃ over)
- Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).
- Known history of active Hepatitis B or C.
- Women who are pregnant or nursing.
- Evidence of any other disease, neurological or metabolic dysfunction, physical examination or laboratory finding giving reasonable suspicion of a disease or condition that contraindicated the use of an investigational drug or puts the subject at high risk for treatment-related complications.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060
Si-Yu Wang, Doctor, +86 20 87343439, wsysums@163.net
About this study
Official title: A Multicenter Phase II Trial of Neoadjuvant IBI308, Bevacizumab, Plus Pemetrexed and Carboplatin Followed by Surgery in Patients With Unresectable Stage III Non-Small Cell Lung Cancer
The purpose of this study is to studying neoadjuvant IBI308, bevacizumab, plus pemetrexed and carboplatin followed by surgery to see how well it works in treating patients with unresectable stage III non-small cell lung cancer.
Read the detailed description
Concurrent chemoradiotherapy is the recommended therapeutic approach for patients with unresectable stage III non-small cell lung cancer (NSCLC), although surgery offers the chance of cure. With combined-modality therapy with radiation therapy and chemotherapy, the prognosis of stage III NSCLC remains poor. IBI308 (sintilimab) is a recombinant humanized anti-PD-1 monoclonal antibody. This study is to studying neoadjuvant IBI308, bevacizumab, plus pemetrexed and carboplatin followed by surgery to see how well it works in treating patients with unresectable stage III non-small cell lung cancer.
- Conditions
- Lung Cancer Stage III
- Being tested
- IBI308, Bevacizumab, Pemetrexed, Carboplatin, Thoracic surgery
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IBI308Drug
Also called Sintilimab
IBI308 was given 200 mg iv infusion on day 1 of each 21-day cycle for 4 cycles.
BevacizumabDrug
Also called Avastin
Bevacizumab was administered at a dose of 15 mg/kg on day 1 of each 21-day cycle for 4 cycles.
PemetrexedDrug
Also called Pemetrexed disodium
Pemetrexed was given 500 mg/m^2 i.v. injection on day 1 of each 21-day cycle for 4 cycles.
CarboplatinDrug
Also called CBP
Carboplatin was given dosed to an area under the serum concentration-time curve (AUC) of 5 i.v. on day 1 of each 21-day cycle for 4 cycles.
Thoracic surgeryProcedure or surgery
Surgery will be performed at least 21 days after the last dose of neoadjuvant therapy.
| Study group | Role | What they receive |
|---|---|---|
| Drug and surgery | Experimental | Neoadjuvant therapy followed by surgery. Neoadjuvant therapy included four drugs. IBI308 was given 200 mg iv infusion on day 1 of each 21-day cycle for 4 cycles; bevacizumab was administered at a dose of 15 mg/kg; pemetrexed was given 500 mg/m^2 i.v. injection on day 1 of each 21-day cycle for 4 cycles; carboplatin was given dosed to an area under the serum concentration-time curve (AUC) of 5 i.v. on day 1 of each 21-day cycle for 4 cycles. Surgery will be performed at least 21 days after the last dose of neoadjuvant therapy. Receives: Drug: IBI308; Drug: Bevacizumab; Drug: Pemetrexed; Drug: Carboplatin; Procedure: Thoracic surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resectability rate
Resectability rate was defined as the percentage of patients who were able to undergo surgery after induction.
Measured: 3 months
Secondary outcomes (1)
Number of participants with perioperative complications
Safety
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2019
- Study start1 Mar 2019
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Cancer Stage IIIStudies 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
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Si-Yu Wang, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03872661
- Sponsor's protocol ID
- GASTO1048
- Acronym
- NIBCUN
- Status last verified
- Apr 2026
- First submitted
- 27 Feb 2019
- Last updated
- 21 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Phase II Trial of Neoadjuvant IBI308, Bevacizumab, Plus Pemetrexed and Carboplatin Followed by Surgery in Patients With Unresectable Stage III Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT03872661
- Acronym / sponsor ID
- NIBCUN / GASTO1048
- Conditions
- Lung Cancer Stage III
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 13 Mar 2019 (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.
The purpose of this study is to studying neoadjuvant IBI308, bevacizumab, plus pemetrexed and carboplatin followed by surgery to see how well it works in treating patients with unresectable stage III non-small cell lung cancer.
Detailed description
Concurrent chemoradiotherapy is the recommended therapeutic approach for patients with unresectable stage III non-small cell lung cancer (NSCLC), although surgery offers the chance of cure. With combined-modality therapy with radiation therapy and chemotherapy, the prognosis of stage III NSCLC remains poor. IBI308 (sintilimab) is a recombinant humanized anti-PD-1 monoclonal antibody. This study is to studying neoadjuvant IBI308, bevacizumab, plus pemetrexed and carboplatin followed by surgery to see how well it works in treating patients with unresectable stage III non-small cell lung cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Drug and surgery | Experimental | Drug: IBI308, Drug: Bevacizumab, Drug: Pemetrexed, Drug: Carboplatin, Procedure: Thoracic surgeryNeoadjuvant therapy followed by surgery. Neoadjuvant therapy included four drugs. IBI308 was given 200 mg iv infusion on day 1 of each 21-day cycle for 4 cycles; bevacizumab was administered at a dose of 15 mg/kg; pemetrexed was given 500 mg/m^2 i.v. injection on day 1 of each 21-day cycle for 4 cycles; carboplatin was given dosed to an area under the serum concentration-time curve (AUC) of 5 i.v. on day 1 of each 21-day cycle for 4 cycles. Surgery will be performed at least 21 days after the last dose of neoadjuvant therapy. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Target population is unresectable stage III non-small cell lung cancer.
- Written informed consent provided.
- Subjects should not have a previously detected sensitizing EGFR mutation or ALK fusion oncogene.
- Male and female patients aged ≥18 years, < 75 years.
- Able to comply with the required protocol and follow-up procedures, and able to receive oral medications.
Key exclusion criteria (15 listed)
- Known severe hypersensitivity to IBI308 or any of the excipients of this product.
- Prior therapy with anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibody (including any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways).
- Prior chemotherapy or radiotherapy.
- Subjects with active, known or suspected autoimmune disease. Subjects in conditions not expected to recur in the absence of an external trigger, or not requiring systemic treatment are permitted to enroll.
- Subjects with a condition requiring systemic treatment with either corticosteroids (>10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of first administration of study treatment. Inhaled or topical steroids, and adrenal replacement steroid doses > 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease.
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 |
|---|---|---|
| IBI308Also: SintilimabIBI308 was given 200 mg iv infusion on day 1 of each 21-day cycle for 4 cycles. | Drug | Drug and surgery |
| BevacizumabAlso: AvastinBevacizumab was administered at a dose of 15 mg/kg on day 1 of each 21-day cycle for 4 cycles. | Drug | Drug and surgery |
| PemetrexedAlso: Pemetrexed disodiumPemetrexed was given 500 mg/m^2 i.v. injection on day 1 of each 21-day cycle for 4 cycles. | Drug | Drug and surgery |
| CarboplatinAlso: CBPCarboplatin was given dosed to an area under the serum concentration-time curve (AUC) of 5 i.v. on day 1 of each 21-day cycle for 4 cycles. | Drug | Drug and surgery |
| Thoracic surgerySurgery will be performed at least 21 days after the last dose of neoadjuvant therapy. | Procedure or surgery | Drug and surgery |
Primary outcome
Resectability rate
Time frame: 3 months
Resectability rate was defined as the percentage of patients who were able to undergo surgery after induction.
1 secondary outcome
Number of participants with perioperative complications
Time frame: 2 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 21 Apr 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing IBI308, Bevacizumab and Pemetrexed in people with Lung Cancer Stage III, run by Sun Yat-sen University at 1 site in China.
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 11 inclusion and 15 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: looking for participants now, as of the sponsor's last update on 21 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Si-Yu Wang, MD (+86 20 87343439, wsysums@163.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Resectability rate (time frame: 3 months). 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 21 Apr 2026.