Non-small Cell Lung CancerPhase 2NCT05460195
Sintilimab Combined With Anlotinib for Perioperative Non-small Cell Lung Cancer Based on MRD Evaluation
A Phase 2 study testing sintilimab combined with anlotinib and sintilimab monotherapy in people with Non-small Cell Lung Cancer and Minimal Residual Disease, run by Shanghai Chest Hospital at 1 site in China.
Trial summary
To study the efficacy of sintilimab combined with anlotinib for perioperative non-small cell lung cancer. To explore the clearance effect of sintilimab combined with anlotinib for postoperative adjuvant therapy based on evaluating minimal residual disease. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Non-small Cell Lung Cancer, Minimal Residual Disease, Immunotherapy
- What is being tested?
- sintilimab combined with anlotinib and sintilimab monotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2022to 31 Dec 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 cyologically confirmed stage II-IIIa NSCLC patients;
- NSCLC patients with negative driver gene: EGFR wild-type, no ALK fusion mutation, no ROS1 fusion mutation;
- ECOG PS: 0~1;
- Pulmonary function index meets the surgical criteria;
- No previous systemic anti-tumor treatment.
Who cannot join
- Patients with central cavitary squamous cell carcinoma or investigator-assessed bleeding symptoms or bleeding tendency were excluded.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Chest Hospital
Shanghai
Changqing Pan
About this study
Official title: Sintilimab Combined With Anlotinib for Perioperative Non-small Cell Lung Cancer Based on MRD Evaluation: a Clinical Study
To study the efficacy of sintilimab combined with anlotinib for perioperative non-small cell lung cancer. To explore the clearance effect of sintilimab combined with anlotinib for postoperative adjuvant therapy based on evaluating minimal residual disease.
Read the detailed description
Patients with resectable non-small cell lung cancer (NSCLC) have a high postoperative recurrence rate. Perioperative treatment, which can improve the resection rate and clear the minimal residual disease, is the main mean of preventing recurrence, including preoperative neoadjuvant and postoperative adjuvant therapies. In recent years, immunotherapy can significantly improve the pathological remission rate and prolong the survival as a perioperative treatment. In addition to single-agent or combined chemotherapy, the exploration of immunotherapy with other therapeutic strategies is still lacking.
In 2018, we originally designed sintilimab combined with anlotinib in the first-line treatment of advanced NSCLC.
This clinical study plans to: ① apply the "de-chemotherapy" model to the perioperative phase of early NSCLC, ② explore sintilimab combined with anlotinib in preoperative neoadjuvant and postoperative adjuvant therapies, ③ explore clearance effect of sintilimab combined with anlotinib for postoperative adjuvant therapy based on evaluating minimal residual disease (MRD), in order to improve the efficacy of perioperative NSCLC and prolong survival.
- Being tested
- sintilimab combined with anlotinib, sintilimab monotherapy
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Neoplasm, Residual
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sintilimab combined with anlotinibDrug
Also called immunotherapy combined with antiangiogenic therapy
Sintilimab (200mg/time, every 3 weeks) combined with anlotinib (12mg, once daily on day 1 to 14 per cycle) for 2 cycles (42 days). Radical surgery is performed within 4 - 6 weeks treatment. Sintilimab combined with anlotinib therapy repeats every 3 weeks until one year after surgery.
sintilimab monotherapyDrug
Also called immunotherapy
Sintilimab (200mg/time, every 3 weeks) combined with anlotinib (12mg, once daily on day 1 to 14 per cycle) for 2 cycles (42 days). Radical surgery is performed within 4 - 6 weeks treatment. Sintilimab monotherapy repeats every 3 weeks until one year after surgery.
| Study group | Role | What they receive |
|---|---|---|
| Combination therapy group | Experimental | Sintilimab combined with anlotinib Receives: Drug: sintilimab combined with anlotinib |
| Single-agent therapy group | Experimental | Sintilimab monotherapy Receives: Drug: sintilimab monotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major pathologic response (MPR)
Residual tumor cells of the surgical specimens were ≤10% based on pathological evaluation.
Measured: 2 months
Secondary outcomes (3)
Complete pathologic response (CPR)
Residual tumor cells of the surgical specimens were 0% based on pathological evaluation.
Measured: 2 months
Event free survival (EFS)
Time from randomization to any of the following: disease progression; new primary NSCLC; death from any cause
Measured: 16 months
Overall survival (OS)
Radiographic assessments were performed when enrolled and every 8 weeks until disease progression after chemotherapy according to RECIST version 1.1. After PD, collect the survival information every 16 weeks until death or withdrawal of study consent.
Measured: 32 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2022
- Study start1 Jan 2022
- Primary completion30 Sep 2024 (estimated)
- Study completion31 Dec 2024 (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 Lung CancerStudies of the same condition, open and under way.
- More trials run by Shanghai Chest 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Chest Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tianqing Chu, Shanghai Chest Hospital
- Investigators
- Tianqing Chu Chu, Principal investigator, Shanghai Chest Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05460195
- Sponsor's protocol ID
- ChestKS22002
- Status last verified
- Jul 2022
- First submitted
- 3 Jul 2022
- Last updated
- 15 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sintilimab Combined With Anlotinib for Perioperative Non-small Cell Lung Cancer Based on MRD Evaluation: a Clinical Study
- ClinicalTrials.gov ID
- NCT05460195
- Acronym / sponsor ID
- ChestKS22002
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Shanghai Chest HospitalUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 15 Jul 2022 (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.
To study the efficacy of sintilimab combined with anlotinib for perioperative non-small cell lung cancer. To explore the clearance effect of sintilimab combined with anlotinib for postoperative adjuvant therapy based on evaluating minimal residual disease.
Detailed description
Patients with resectable non-small cell lung cancer (NSCLC) have a high postoperative recurrence rate. Perioperative treatment, which can improve the resection rate and clear the minimal residual disease, is the main mean of preventing recurrence, including preoperative neoadjuvant and postoperative adjuvant therapies. In recent years, immunotherapy can significantly improve the pathological remission rate and prolong the survival as a perioperative treatment. In addition to single-agent or combined chemotherapy, the exploration of immunotherapy with other therapeutic strategies is still lacking.
In 2018, we originally designed sintilimab combined with anlotinib in the first-line treatment of advanced NSCLC.
This clinical study plans to: ① apply the "de-chemotherapy" model to the perioperative phase of early NSCLC, ② explore sintilimab combined with anlotinib in preoperative neoadjuvant and postoperative adjuvant therapies, ③ explore clearance effect of sintilimab combined with anlotinib for postoperative adjuvant therapy based on evaluating minimal residual disease (MRD), in order to improve the efficacy of perioperative NSCLC and prolong survival.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Combination therapy group | Experimental | Drug: sintilimab combined with anlotinibSintilimab combined with anlotinib |
| Single-agent therapy group | Experimental | Drug: sintilimab monotherapySintilimab monotherapy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Histologically or cyologically confirmed stage II-IIIa NSCLC patients;
- NSCLC patients with negative driver gene: EGFR wild-type, no ALK fusion mutation, no ROS1 fusion mutation;
- ECOG PS: 0~1;
- Pulmonary function index meets the surgical criteria;
- No previous systemic anti-tumor treatment.
Key exclusion criteria (1 listed)
- Patients with central cavitary squamous cell carcinoma or investigator-assessed bleeding symptoms or bleeding tendency were excluded.
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 |
|---|---|---|
| sintilimab combined with anlotinibAlso: immunotherapy combined with antiangiogenic therapySintilimab (200mg/time, every 3 weeks) combined with anlotinib (12mg, once daily on day 1 to 14 per cycle) for 2 cycles (42 days). Radical surgery is performed within 4 - 6 weeks treatment. Sintilimab combined with anlotinib therapy repeats every 3 weeks until one year after surgery. | Drug | Combination therapy group |
| sintilimab monotherapyAlso: immunotherapySintilimab (200mg/time, every 3 weeks) combined with anlotinib (12mg, once daily on day 1 to 14 per cycle) for 2 cycles (42 days). Radical surgery is performed within 4 - 6 weeks treatment. Sintilimab monotherapy repeats every 3 weeks until one year after surgery. | Drug | Single-agent therapy group |
Primary outcome
Major pathologic response (MPR)
Time frame: 2 months
Residual tumor cells of the surgical specimens were ≤10% based on pathological evaluation.
3 secondary outcomes
Complete pathologic response (CPR)
Time frame: 2 months
Event free survival (EFS)
Time frame: 16 months
Overall survival (OS)
Time frame: 32 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2022.
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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. This study is not recruiting at the moment.
Tianqing Chu Chu principal investigator
Shanghai Chest Hospital
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 sintilimab combined with anlotinib and sintilimab monotherapy in people with Non-small Cell Lung Cancer and Minimal Residual Disease, run by Shanghai Chest 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 5 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 15 Jul 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tianqing Chu (13661775640, tianqing_chu@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major pathologic response (MPR) (time frame: 2 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 15 Jul 2022.