SintilimabPhase 2NCT05400070
Neoadjuvant PD-1 Inhibitor (Sintilimab), Anlotinib Combined With Chemotherapy in Resectable Stage IIA-IIIB NSCLC
A Phase 2 study testing Neoadjuvant therapy 1 in people with Sintilimab and Lung Cancer, run by Tang-Du Hospital at 1 site in China.
Trial summary
primary purpose：Observe the pathological complete response rate (PCR) of postoperative tumor tissue resection and evaluate the safety of the treatment process. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Sintilimab, Lung Cancer, Anlotinib
- What is being tested?
- Neoadjuvant therapy 1
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2021to 30 Dec 2026
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- pathological diagnosis of lung cancer, Age 18 years and 75 years old, physical strength status score 0-1;
- The investigator believes that the subject can comply with the study protocol;
- The investigator has confirmed to have at least one measurable lesion according to the RECIST1.1 criteria;
- Stage IIA, IIB, IIIA, IIIB NSCLC with histological or cytology proven operable treatment according to the International Association for Lung Cancer Research and the American Joint Committee on Cancer Staging version 8;
- Good hematopoietic function, defined as absolute neutrophil number 1.5X109 / L (no granulocyte colony stimulating factor support therapy), platelet count 100X109 / L, hemoglobin 90 g / L; (no transfusion or no erythropoietin dependence within 7 days);
- Good liver function, defined as 1.5 times the normal limit (ULN) of serum total bilirubin; ULN at 2.5 times transaminase (AST) and ALT); AST and ALT for recorded ULN;
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- Good renal function, defined as serum creatinine 1.5 times ULN or calculated creatinine clearance of 60 ml/min (Cockcroft-Gault formula); routine urine protein less than 2 +, or 24h urine protein <1g;
- Good coagulation function, defined as the international standardized ratio (INR) or prothrombin time (PT) 1.5 times ULN;
- The total amount of lung function (e. g., FVC, FEV1, TLC, FRC, and DLco) can tolerate the proposed lung resection procedure;
- For female subjects of childbearing age, the urine or serum pregnancy test should be negative within 3 days before receiving the first dose (cycle 1, day 1)
Who cannot join
- 1 . Presof locally advanced unresectable or metastatic disease;
- 2.. peripheral neuropathy;
- 3.Active, known or suspected autoimmune diseases, type I diabetes, hypothyroidism that requires only hormone replacement therapy, skin diseases that do not require systemic treatment (such as vitiligo, psoriasis or alopecia), or diseases not expected to recur without external stimulus factors can be selected;
- 4. Systemic treatment with corticosteroids (an equivalent dose of> 10 mg prednisone per day) or other immunosuppressive drugs within 14 days before randomization.Inhalor topical steroids are permitted without active autoimmune disease.
- 5.Active Hepatitis B / hepatitis C infection and known HIV;
- 6.Patients who have previously received chemotherapy or any other anti-tumor therapy;
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-arm Clinical Study to Investigate the Efficacy and Safety of Neoadjuvant PD-1 Inhibitor (Sintilimab), Anlotinib Combined With Chemotherapy in Resectable Stage IIA-IIIB NSCLC
primary purpose：Observe the pathological complete response rate (PCR) of postoperative tumor tissue resection and evaluate the safety of the treatment process.
Read the detailed description
primary purpose：Observe the pathological complete response rate (PCR) of postoperative tumor tissue resection and evaluate the safety of the treatment process.
Description of the study design This is a single-center, prospective, open-label, single-arm clinical study to preliminarily explore the single-arm clinical study administration and drug management of Sintilimab, anlotinib combined with neoadjuvant chemotherapy in stage IIA-IIIB NSCLC
Dosing regimen Sintilimab (200mg fixed dose) iv, d1, q3w + anlotinib 10mg, po, qd1-14, q3w, was evaluated after 3 cycles of chemotherapy and stopped for 3 weeks (21 days) after surgery for 4-6 weeks (21-42 days) after the last dose.
- Conditions
- Sintilimab, Lung Cancer, Anlotinib, Chemotherapy
- Being tested
- Neoadjuvant therapy 1
- Keywords
- Sintilimab, Anlotinib. chemotherapy. safety. efficacy
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neoadjuvant therapy 1Drug
Also called anlotinib 10mg, po, qd1-14, q3w, Chemotherapy, Sintilimab (200mg fixed dose) iv, d1, q3w
Dosing regimen Sintilimab (200mg fixed dose) iv, d1, q3w + anlotinib 10mg, po, qd1-14, q3w, was evaluated after 3 cycles of chemotherapy and stopped for 3 weeks (21 days) after surgery for 4-6 weeks (21-42 days) after the last dose.
| Study group | Role | What they receive |
|---|---|---|
| neoadjuvant therapy | Experimental | Sintilimab (200mg fixed dose) iv, d1, q3w，anlotinib 10mg, po, qd1-14, q3w combine with Chemotherapy Receives: Drug: Neoadjuvant therapy 1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
pathological complete response (PCR)
pathological complete response (PCR)
Measured: 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 posted1 Jun 2022
- Study start1 Mar 2021
- Primary completion30 Dec 2023
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SintilimabStudies of the same condition, open and under way.
- More trials run by Tang-Du 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
- Not applicable
- Intervention model
- Single group
- Model description
- Sintilimab (200mg fixed dose) iv, d1, q3w + anlotinib 10mg, po, qd1-14, q3w, was evaluated after 3 cycles of chemotherapy and stopped for 3 weeks (21 days) after surgery for 4-6 weeks (21-42 days) after the last dose.
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tang-Du Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05400070
- Sponsor's protocol ID
- K202104-03
- Status last verified
- Oct 2024
- First submitted
- 18 May 2022
- Last updated
- 18 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Duan H, Shao C, Luo Z, Wang T, Tong L, Liu H, Yao X, Lei J, Zhao J, Gao Y, Jiang T, Yan X. Perioperative sintilimab and neoadjuvant anlotinib plus chemotherapy for resectable non-small-cell lung cancer: a multicentre, open-label, single-arm, phase 2 trial (TD-NeoFOUR trial). Signal Transduct Target Ther. 2024 Oct 28;9(1):296. doi: 10.1038/s41392-024-01992-0.
PubMed 39465257
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-arm Clinical Study to Investigate the Efficacy and Safety of Neoadjuvant PD-1 Inhibitor (Sintilimab), Anlotinib Combined With Chemotherapy in Resectable Stage IIA-IIIB NSCLC
- ClinicalTrials.gov ID
- NCT05400070
- Acronym / sponsor ID
- K202104-03
- Conditions
- Sintilimab, Lung Cancer, Anlotinib, Chemotherapy
- Keywords
- Sintilimab, Anlotinib. chemotherapy. safety. efficacy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Tang-Du HospitalUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 30 Dec 2023 (actual)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 1 Jun 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.
primary purpose：Observe the pathological complete response rate (PCR) of postoperative tumor tissue resection and evaluate the safety of the treatment process.
Detailed description
primary purpose：Observe the pathological complete response rate (PCR) of postoperative tumor tissue resection and evaluate the safety of the treatment process.
Description of the study design This is a single-center, prospective, open-label, single-arm clinical study to preliminarily explore the single-arm clinical study administration and drug management of Sintilimab, anlotinib combined with neoadjuvant chemotherapy in stage IIA-IIIB NSCLC
Dosing regimen Sintilimab (200mg fixed dose) iv, d1, q3w + anlotinib 10mg, po, qd1-14, q3w, was evaluated after 3 cycles of chemotherapy and stopped for 3 weeks (21 days) after surgery for 4-6 weeks (21-42 days) after the last dose.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Sintilimab (200mg fixed dose) iv, d1, q3w + anlotinib 10mg, po, qd1-14, q3w, was evaluated after 3 cycles of chemotherapy and stopped for 3 weeks (21 days) after surgery for 4-6 weeks (21-42 days) after the last dose.
| Arm | Type | Receives |
|---|---|---|
| neoadjuvant therapy | Experimental | Drug: Neoadjuvant therapy 1Sintilimab (200mg fixed dose) iv, d1, q3w，anlotinib 10mg, po, qd1-14, q3w combine with Chemotherapy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- pathological diagnosis of lung cancer, Age 18 years and 75 years old, physical strength status score 0-1;
- The investigator believes that the subject can comply with the study protocol;
- The investigator has confirmed to have at least one measurable lesion according to the RECIST1.1 criteria;
- Stage IIA, IIB, IIIA, IIIB NSCLC with histological or cytology proven operable treatment according to the International Association for Lung Cancer Research and the American Joint Committee on Cancer Staging version 8;
- Good hematopoietic function, defined as absolute neutrophil number 1.5X109 / L (no granulocyte colony stimulating factor support therapy), platelet count 100X109 / L, hemoglobin 90 g / L; (no transfusion or no erythropoietin dependence within 7 days);
Key exclusion criteria (6 listed)
- 1 . Presof locally advanced unresectable or metastatic disease;
- 2.. peripheral neuropathy;
- 3.Active, known or suspected autoimmune diseases, type I diabetes, hypothyroidism that requires only hormone replacement therapy, skin diseases that do not require systemic treatment (such as vitiligo, psoriasis or alopecia), or diseases not expected to recur without external stimulus factors can be selected;
- 4. Systemic treatment with corticosteroids (an equivalent dose of> 10 mg prednisone per day) or other immunosuppressive drugs within 14 days before randomization.Inhalor topical steroids are permitted without active autoimmune disease.
- 5.Active Hepatitis B / hepatitis C infection and known HIV;
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 |
|---|---|---|
| Neoadjuvant therapy 1Also: anlotinib 10mg, po, qd1-14, q3w, Chemotherapy, Sintilimab (200mg fixed dose) iv, d1, q3wDosing regimen Sintilimab (200mg fixed dose) iv, d1, q3w + anlotinib 10mg, po, qd1-14, q3w, was evaluated after 3 cycles of chemotherapy and stopped for 3 weeks (21 days) after surgery for 4-6 weeks (21-42 days) after the last dose. | Drug | neoadjuvant therapy |
Primary outcome
pathological complete response (PCR)
Time frame: up to 4 months
pathological complete response (PCR)
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 18 Oct 2024.
- Derived from this study: PubMed 39465257Duan H, Shao C, Luo Z, Wang T, Tong L, Liu H, Yao X, Lei J, Zhao J, Gao Y, Jiang T, Yan X. Perioperative sintilimab and neoadjuvant anlotinib plus chemotherapy for resectable non-small-cell lung cancer: a multicentre, open-label, single-arm, phase 2 trial (TD-NeoFOUR trial). Signal Transduct Target Ther. 2024 Oct 28;9(1):296. doi: 10.1038/s41392-024-01992-0.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Neoadjuvant therapy 1 in people with Sintilimab and Lung Cancer, run by Tang-Du 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 10 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 18 Oct 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.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pathological complete response (PCR) (time frame: up to 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05400070, which also lists 1 linked publication.
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 18 Oct 2024.