NSCLCPhase 2SeagullNCT05286957
MRD-guided Adjuvant Tislelizumab and Chemotherapy in Resected Stage IIA-IIIB NSCLC
A Phase 2 study testing adjuvant tislelizumab and chemotherapy for MRD+ patients and adjuvant chemotherapy for MRD- patients in people with NSCLC, run by The First Affiliated Hospital of Zhengzhou University at 1 site in China.
Trial summary
Seagull is a phase Ⅱ study designed to investigate the efficacy and safety of MRD-guided adjuvant tislelizumab and chemotherapy vs adjuvant tislelizumab and chemotherapy in patients with resectable NSCLC Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- NSCLC
- What is being tested?
- adjuvant tislelizumab and chemotherapy for MRD+ patients and adjuvant chemotherapy for MRD- patients
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 20 Jun 2022to 1 Jun 2027
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient with age ≥ 18 years old, gender is not limited.
- Histologically confirmed primary NSCLC, postoperative stage is IIA, IIB, IIIA or T3N2IIIB.
- Receiving complete resection
- Paraffin-embedded sections (10-15 pieces) or fresh frozen tissue are required.
- ECOG score of 0 or 1.
- Females of childbearing age should take appropriate contraceptive measures from screening to 3 months after discontinuation of study treatment and should not breastfeed. The pregnancy test was negative before starting dosing.
- Male patients should use barrier contraception from screening to 3 months after discontinuation of study treatment.
- The subjects themselves participated voluntarily and signed the informed consent in writing.
Who cannot join
- The patient has received immune checkpoint inhibitors such as anti-PD-1, PD-L1 or CTLA-4, other immunotherapy or systemic immune modulators (including but not limited to interferon, IL-2 and TNF etc).
- Histopathology with small cell or large cell endocrine tumor component.
- Harboring EGFR sensitizing mutation or ALK gene translocation
- History of other malignant tumors, except for non-melanoma skin cancer, carcinoma in situ or other solid tumors that have been effectively treated, and no evidence of any disease for >5 years after the last treatment.
- At the start of the study treatment, there are residual toxicities of the previous treatment that are greater than CTCAE 1 and have not been alleviated, except for alopecia and grade 2 neurotoxicity caused by previous chemotherapy.
- Any serious or uncontrolled systemic disease, including uncontrolled high blood pressure, active bleeding, active infection including hepatitis B, C, HIV, etc., which the investigator considers unsuitable to participate in the study or affect the trial program compliance.
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- History of ILD, drug-induced interstitial lung disease, radiation pneumonitis requiring steroid therapy, or any evidence of clinically active interstitial lung disease
- Insufficient bone marrow reserve or organ function.
- History of hypersensitivity reactions to any active or inactive ingredient of tislelizumab or to drugs that are chemically similar to tislelizumab or in the same class of tislelizumab.
- Patients who, in the judgment of the investigator, may not comply with the procedures and requirements of the study.
- Patients who, in the investigator's judgment, have any condition that compromises patient safety or interferes with the evaluation of the study.
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
The First Affiliated Hospital of Zhengzhou University,
Zhengzhou, Henan, 450052
Feng Li, MD, +8615838222689, LF_0604@163.com
About this study
Official title: Minimal Residual Disease (MRD)-Guided Adjuvant Tislelizumab and Chemotherapy in Resected Stage IIA-IIIB Non-small Cell Lung Cancer (NSCLC): a Randomized Controlled Phase II Study (Seagull)
Seagull is a phase Ⅱ study designed to investigate the efficacy and safety of MRD-guided adjuvant tislelizumab and chemotherapy vs adjuvant tislelizumab and chemotherapy in patients with resectable NSCLC
Read the detailed description
In the phase II trial, the efficacy and safety of MRD-guided adjuvant tislelizumab and chemotherapy will be compared with that of standard adjuvant tislelizumab and chemotherapy in patients with resectable NSCLC.
- Conditions
- NSCLC
- Being tested
- adjuvant tislelizumab and chemotherapy for MRD+ patients, adjuvant chemotherapy for MRD- patients
- Keywords
- ctDNA-MRD
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
adjuvant tislelizumab and chemotherapy for MRD+ patientsDrug
MRD+ patients receive adjuvant tislelizumab and chemotherapy while MRD- patients just is recommended receive adjuvant chemotherapy untill be detected MRD+
adjuvant tislelizumab and chemotherapy (cisplatin/carboplatin + paclitaxel or cisplatin/carboplatin + pemetrexed,dependent on tumor histology and at investigator's discretion)
adjuvant tislelizumab and chemotherapy for MRD+ patientsDrug
patients receive adjuvant tislelizumab and chemotherapy regardless of MRD status
adjuvant chemotherapy for MRD- patientsDrug
MRD- patients just be recommended receive adjuvant chemotherapy untill be detected cisplatin/carboplatin + paclitaxel or cisplatin/carboplatin + pemetrexed,dependent on tumor histology and at investigator's discretion, limited to ≤4 cycles
| Study group | Role | What they receive |
|---|---|---|
| MRD-guided adjuvant tislelizumab and chemotherapy | Experimental | MRD+: Tislelizumab 200mg Q3W + chemotherapy 1-4 cycles and followed by Tislelizumab 200mg Q3W Up to 16 cycles or until PD or intolerable toxicity or withdrawal
MRD-: Adjuvant chemotherapy and surveillance the MRD status, the patient will receive treatment for MRD+ patient when MRD detected, Receives: Drug: adjuvant tislelizumab and chemotherapy for MRD+ patients |
| Non MRD-guided adjuvant tislelizumab and chemotherapy | Active comparator | patients in non MRD-guided arm receive adjuvant tislelizumab and chemotherapy Receives: Drug: adjuvant tislelizumab and chemotherapy for MRD+ patients; Drug: adjuvant chemotherapy for MRD- patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
2-year PFS rate
Progression-free survival (per RECIST 1.1) is defined as the time from the starting date of study drug to the date of first documentation of disease progression or death, whichever occurs first. Subjects who do not have disease progression will be censored at their last valid tumor assessment. PFS rate at 1 year as estimated by Kaplan-Meier method.
Measured: up to 36 months after enrollment or study close
Secondary outcomes (1)
Percentage of patients changed from MRD+ to MRD- after treatment with tislelizumab for 6 months，12 months
Percentage of patients changed from MRD+ to MRD- after treatment with Tislelizumab for 9 months，12months
Measured: At the end of Cycle 8(each cycle is 21 days)、Cycle 16 (each cycle is 21 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2022
- Study start20 Jun 2022
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSCLCStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Zhengzhou 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- BeiGene
- Responsible party
- Principal investigator, Qi Yu, The First Affiliated Hospital of Zhengzhou University
- Investigators
- Yu Qi, Principal investigator, The First Affiliated Hospital of Zhengzhou University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05286957
- Sponsor's protocol ID
- L2021-Y471
- Acronym
- Seagull
- Status last verified
- Mar 2023
- First submitted
- 1 Mar 2022
- Last updated
- 17 Mar 2023
- 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 17 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Minimal Residual Disease (MRD)-Guided Adjuvant Tislelizumab and Chemotherapy in Resected Stage IIA-IIIB Non-small Cell Lung Cancer (NSCLC): a Randomized Controlled Phase II Study (Seagull)
- ClinicalTrials.gov ID
- NCT05286957
- Acronym / sponsor ID
- Seagull / L2021-Y471
- Conditions
- NSCLC
- Keywords
- ctDNA-MRD
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Zhengzhou UniversityUniversity, hospital or other
- Collaborators
- BeiGene
- Study start
- 20 Jun 2022 (actual)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 18 Mar 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.
Seagull is a phase Ⅱ study designed to investigate the efficacy and safety of MRD-guided adjuvant tislelizumab and chemotherapy vs adjuvant tislelizumab and chemotherapy in patients with resectable NSCLC
Detailed description
In the phase II trial, the efficacy and safety of MRD-guided adjuvant tislelizumab and chemotherapy will be compared with that of standard adjuvant tislelizumab and chemotherapy in patients with resectable NSCLC.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MRD-guided adjuvant tislelizumab and chemotherapy | Experimental | Drug: adjuvant tislelizumab and chemotherapy for MRD+ patientsMRD+: Tislelizumab 200mg Q3W + chemotherapy 1-4 cycles and followed by Tislelizumab 200mg Q3W Up to 16 cycles or until PD or intolerable toxicity or withdrawal MRD-: Adjuvant chemotherapy and surveillance the MRD status, the patient will receive treatment for MRD+ patient when MRD detected, |
| Non MRD-guided adjuvant tislelizumab and chemotherapy | Active comparator | Drug: adjuvant tislelizumab and chemotherapy for MRD+ patients, Drug: adjuvant chemotherapy for MRD- patientspatients in non MRD-guided arm receive adjuvant tislelizumab and chemotherapy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patient with age ≥ 18 years old, gender is not limited.
- Histologically confirmed primary NSCLC, postoperative stage is IIA, IIB, IIIA or T3N2IIIB.
- Receiving complete resection
- Paraffin-embedded sections (10-15 pieces) or fresh frozen tissue are required.
- ECOG score of 0 or 1.
Key exclusion criteria (11 listed)
- The patient has received immune checkpoint inhibitors such as anti-PD-1, PD-L1 or CTLA-4, other immunotherapy or systemic immune modulators (including but not limited to interferon, IL-2 and TNF etc).
- Histopathology with small cell or large cell endocrine tumor component.
- Harboring EGFR sensitizing mutation or ALK gene translocation
- History of other malignant tumors, except for non-melanoma skin cancer, carcinoma in situ or other solid tumors that have been effectively treated, and no evidence of any disease for >5 years after the last treatment.
- At the start of the study treatment, there are residual toxicities of the previous treatment that are greater than CTCAE 1 and have not been alleviated, except for alopecia and grade 2 neurotoxicity caused by previous chemotherapy.
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 |
|---|---|---|
| adjuvant tislelizumab and chemotherapy for MRD+ patientsMRD+ patients receive adjuvant tislelizumab and chemotherapy while MRD- patients just is recommended receive adjuvant chemotherapy untill be detected MRD+ adjuvant tislelizumab and chemotherapy (cisplatin/carboplatin + paclitaxel or cisplatin/carboplatin + pemetrexed,dependent on tumor histology and at investigator's discretion) | Drug | MRD-guided adjuvant tislelizumab and chemotherapy, Non MRD-guided adjuvant tislelizumab and chemotherapy |
| adjuvant tislelizumab and chemotherapy for MRD+ patientspatients receive adjuvant tislelizumab and chemotherapy regardless of MRD status | Drug | MRD-guided adjuvant tislelizumab and chemotherapy |
| adjuvant chemotherapy for MRD- patientsMRD- patients just be recommended receive adjuvant chemotherapy untill be detected cisplatin/carboplatin + paclitaxel or cisplatin/carboplatin + pemetrexed,dependent on tumor histology and at investigator's discretion, limited to ≤4 cycles | Drug | Non MRD-guided adjuvant tislelizumab and chemotherapy |
Primary outcome
2-year PFS rate
Time frame: up to 36 months after enrollment or study close
Progression-free survival (per RECIST 1.1) is defined as the time from the starting date of study drug to the date of first documentation of disease progression or death, whichever occurs first. Subjects who do not have disease progression will be censored at their last valid tumor assessment. PFS rate at 1 year as estimated by Kaplan-Meier method.
1 secondary outcome
Percentage of patients changed from MRD+ to MRD- after treatment with tislelizumab for 6 months，12 months
Time frame: At the end of Cycle 8(each cycle is 21 days)、Cycle 16 (each cycle is 21 days)
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 17 Mar 2023.
- 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.
Yu Qi principal investigator
The First Affiliated Hospital of Zhengzhou University
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 adjuvant tislelizumab and chemotherapy for MRD+ patients and adjuvant chemotherapy for MRD- patients in people with NSCLC, run by The First Affiliated Hospital of Zhengzhou 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 8 inclusion and 11 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 17 Mar 2023. 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 Feng Li, MD (+8615838222689, LF_0604@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
2-year PFS rate (time frame: up to 36 months after enrollment or study close). 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 17 Mar 2023.