Lung Neoplasm MalignantNCT04973293
Preoperative Sintilimab Combined With Bevacizumab and Chemotherapy for Resectable Non-Small Cell Lung Cancer
A study testing sintilimab and bevacizumab in people with Lung Neoplasm Malignant, run by Ruijin Hospital at 1 site in China.
Trial summary
Neoadjuvant chemotherapy followed by surgery has been recommended as the standard treatment for locally advanced and resectable non-small cell lung cancer (NSCLC). However, its efficacy remains to be improved. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Lung Neoplasm Malignant
- What is being tested?
- sintilimab and bevacizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2022to 31 Dec 2025
- Phase
- Interventional
- 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
- Histologically or cytologically confirmed, previously untreated and surgically resectable non-small cell lung cancer (stage II-IIIA, patients with squamous cell carcinoma or EGFR mutation should not be included);
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1;
- Satisfactory preoperative laboratory testing and adequate pulmonary function for surgery;
- Patients approve and sign the informed consent.
Who cannot join
- Pancoast tumor, squamous cell carcinoma, large-cell carcinoma and sarcomatoid carcinoma;
- Patients with active autoimmune disease or history of autoimmune disease;
- Patients who have a condition requiring systemic treatment with either prednisone or other immunosuppressive medications;
- Patients with a history of symptomatic interstitial lung disease;
- History of allergy to study drug components;
- Women must not be pregnant or breast-feeding;
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- Men with female partners that are not willing to use contraception;
- Patients who have received prior chemotherapy, anti-angiogenesis therapy and immunotherapy for this malignancy or for any other past malignancy;
- Patients who have received prior treatment for non-small cell lung cancer;
- Any mental or psychological condition which would not permit the patient to complete the study or understand the patient information;
- Patients who have major hemoptysis within the past 4 weeks, tumor has invasion or is close to great vessels;
- Patients with high risk of major bleeding;
- Patients who have arterial thrombotic events, esophageal varices, peptic ulcers, wounds or bone fractures;
- Patients who have prior malignancies;
- HIV, HBV, HCV infection or active pulmonary tuberculosis;
- Underlying medical conditions that, in the Investigator's opinion, will make the administration of study drug hazardous or obscure the interpretation of toxicity or adverse events.
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
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200025
Hecheng Li, MD,PHD, 0086-021-64370045, lihecheng2000@hotmail.com
Yuyan Zheng, MD, 0086-15280093677, yuyanzheng@outlook.com
About this study
Official title: The Safety and Feasibility of Preoperative Sintilimab Combined With Bevacizumab and Chemotherapy for Locally Advanced Resectable Non-Small Cell Lung Cancer
Neoadjuvant chemotherapy followed by surgery has been recommended as the standard treatment for locally advanced and resectable non-small cell lung cancer (NSCLC). However, its efficacy remains to be improved. Drugs targeting PD-1/PD-L1 pathway have been proven to be effective for late-stage NSCLC, and anti-angiogenesis agents targeting VEGF (bevacizumab) has also been used for the first line treatment of advanced or metastatic NSCLC. Therefore, we conduct this single-arm clinical trial, which aims to investigate the safety and feasibility of neoadjuvant sintilimab combined with bevacizumab and chemotherapy followed by surgery in treating locally advanced and resectable NSCLC.
Read the detailed description
Lung cancer is one of the most common malignancies around the world. Neoadjuvant chemotherapy followed by surgery has been recommended as the standard treatment for locally advanced and resectable non-small cell lung cancer (NSCLC). However, its efficacy remains to be improved. Bevacizumab targeting VEGF is a widely used antitumor drugs in different types of malignancies, including late-stage NSCLC. Immune checkpoint inhibitor (ICI) targeting PD-1 has also been confirmed to be effective in NSCLC patients. Therefore, we conduct this prospective single-arm clinical trial, to investigate the safety and feasibility of neoadjuvant sintilimab (ICI targeting PD-1) combined with bevacizumab and chemotherapy followed by surgery in treating locally advanced and resectable NSCLC. Twenty patients with stage II-IIIA NSCLC will be enrolled. And the primary endpoint of this study is the safety of this newly developed neoadjuvant treatment. The secondary endpoints are feasibility, radiological response and rate of major pathological response.
- Conditions
- Lung Neoplasm Malignant
- Being tested
- sintilimab, bevacizumab
- Keywords
- Non-small cell lung cancer, Neoadjuvant therapy, Immunotherapy
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sintilimabDrug
Also called IBI308, Xindili Dankang
Sintilimab 200 mg, 4 cycles of treatment before surgery
bevacizumabDrug
Also called Bei Fa Zhu Dankang Zhusheye
bevacizumab 15 mg/kg, 4 cycles of treatment before surgery
| Study group | Role | What they receive |
|---|---|---|
| Neoadjuvant treatment | Experimental | Participants will receive 4 doses of sintilimab (200 mg, IV) and bevacizumab (15 mg/kg, IV) every 3 weeks (Q3W). Participants will also receive 4 doses of carboplatin (AUC=5, IV) and pemetrexed (500 mg/m2, IV) Q3W.
Surgery will be performed within 4 to 6 weeks after completion of preoperative therapy.
After the second dose of sintilimab, bevacizumab and chemotherapy, contrast-enhanced chest CT will be performed. Patients with progression disease will receive surgery without the last 2 doses of treatment. Receives: Drug: sintilimab; Drug: bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety (Rate of grade 3 and higher grade treatment-related adverse events)
Adverse events will be evaluated and recorded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (version 5.0).
Measured: From date of treatment allocation until surgery or up to at least 90 days after last dose of preoperative treatment
Secondary outcomes (3)
Feasibility (Completion rate of neoadjuvant treatment and surgery)
Propotion of participants who complete neoadjuvant treatment and receive surgery within 42 days after preoperative therapies.
Measured: From date of treatment allocation until surgery, assessed up to 5 months
Major Pathological Response Rate
Major pathologic response is predefined as no more than 10% of residual viable tumor cells in primary lesions.
Measured: Two weeks after surgery
Radiographic Response
Radiographic response will be evaluated according to the Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.
Measured: From date of treatment allocation and during treatment period up to 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2021
- Study start1 Oct 2022
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Neoplasm MalignantStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hecheng Li M.D., Ph.D, Ruijin Hospital
- Investigators
- Hecheng Li, MD, PhD, Principal investigator, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04973293
- Sponsor's protocol ID
- RTS-014
- Status last verified
- Nov 2024
- First submitted
- 13 Jul 2021
- Last updated
- 19 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety and Feasibility of Preoperative Sintilimab Combined With Bevacizumab and Chemotherapy for Locally Advanced Resectable Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT04973293
- Acronym / sponsor ID
- RTS-014
- Conditions
- Lung Neoplasm Malignant
- Keywords
- Non-small cell lung cancer, Neoadjuvant therapy, Immunotherapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 22 Jul 2021 (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.
Neoadjuvant chemotherapy followed by surgery has been recommended as the standard treatment for locally advanced and resectable non-small cell lung cancer (NSCLC). However, its efficacy remains to be improved. Drugs targeting PD-1/PD-L1 pathway have been proven to be effective for late-stage NSCLC, and anti-angiogenesis agents targeting VEGF (bevacizumab) has also been used for the first line treatment of advanced or metastatic NSCLC. Therefore, we conduct this single-arm clinical trial, which aims to investigate the safety and feasibility of neoadjuvant sintilimab combined with bevacizumab and chemotherapy followed by surgery in treating locally advanced and resectable NSCLC.
Detailed description
Lung cancer is one of the most common malignancies around the world. Neoadjuvant chemotherapy followed by surgery has been recommended as the standard treatment for locally advanced and resectable non-small cell lung cancer (NSCLC). However, its efficacy remains to be improved. Bevacizumab targeting VEGF is a widely used antitumor drugs in different types of malignancies, including late-stage NSCLC. Immune checkpoint inhibitor (ICI) targeting PD-1 has also been confirmed to be effective in NSCLC patients. Therefore, we conduct this prospective single-arm clinical trial, to investigate the safety and feasibility of neoadjuvant sintilimab (ICI targeting PD-1) combined with bevacizumab and chemotherapy followed by surgery in treating locally advanced and resectable NSCLC. Twenty patients with stage II-IIIA NSCLC will be enrolled. And the primary endpoint of this study is the safety of this newly developed neoadjuvant treatment. The secondary endpoints are feasibility, radiological response and rate of major pathological response.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neoadjuvant treatment | Experimental | Drug: sintilimab, Drug: bevacizumabParticipants will receive 4 doses of sintilimab (200 mg, IV) and bevacizumab (15 mg/kg, IV) every 3 weeks (Q3W). Participants will also receive 4 doses of carboplatin (AUC=5, IV) and pemetrexed (500 mg/m2, IV) Q3W. Surgery will be performed within 4 to 6 weeks after completion of preoperative therapy. After the second dose of sintilimab, bevacizumab and chemotherapy, contrast-enhanced chest CT will be performed. Patients with progression disease will receive surgery without the last 2 doses of treatment. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Histologically or cytologically confirmed, previously untreated and surgically resectable non-small cell lung cancer (stage II-IIIA, patients with squamous cell carcinoma or EGFR mutation should not be included);
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1;
- Satisfactory preoperative laboratory testing and adequate pulmonary function for surgery;
- Patients approve and sign the informed consent.
Key exclusion criteria (16 listed)
- Pancoast tumor, squamous cell carcinoma, large-cell carcinoma and sarcomatoid carcinoma;
- Patients with active autoimmune disease or history of autoimmune disease;
- Patients who have a condition requiring systemic treatment with either prednisone or other immunosuppressive medications;
- Patients with a history of symptomatic interstitial lung disease;
- History of allergy to study drug components;
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 |
|---|---|---|
| sintilimabAlso: IBI308, Xindili DankangSintilimab 200 mg, 4 cycles of treatment before surgery | Drug | Neoadjuvant treatment |
| bevacizumabAlso: Bei Fa Zhu Dankang Zhusheyebevacizumab 15 mg/kg, 4 cycles of treatment before surgery | Drug | Neoadjuvant treatment |
Primary outcome
Safety (Rate of grade 3 and higher grade treatment-related adverse events)
Time frame: From date of treatment allocation until surgery or up to at least 90 days after last dose of preoperative treatment
Adverse events will be evaluated and recorded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (version 5.0).
3 secondary outcomes
Feasibility (Completion rate of neoadjuvant treatment and surgery)
Time frame: From date of treatment allocation until surgery, assessed up to 5 months
Major Pathological Response Rate
Time frame: Two weeks after surgery
Radiographic Response
Time frame: From date of treatment allocation and during treatment period up to 4 months
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 19 Nov 2024.
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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.
Hecheng Li, MD, PhD principal investigator
Ruijin Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sintilimab and bevacizumab in people with Lung Neoplasm Malignant, run by Ruijin Hospital 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 4 inclusion and 16 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 19 Nov 2024. 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.
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 Hecheng Li, MD, PhD (0086-021-64370045, lihecheng2000@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety (Rate of grade 3 and higher grade treatment-related adverse events) (time frame: From date of treatment allocation until surgery or up to at least 90 days after last dose of preoperative treatment). 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 19 Nov 2024.