Double BlindPhase 2/3NCT07662395
SCTB41 Combined With Chemotherapy in Advanced Squamous Non-Small Cell Lung Cancer
A Phase 2/3 study testing SCTB41, Tislelizumab and Paclitaxel in people with Double Blind, run by Sinocelltech Ltd. at 1 site in China.
Trial summary
This is a multicenter Phase II/III study evaluating the efficacy and safety of SCTB41 combined with chemotherapy versus tislelizumab combined with chemotherapy as first-line treatment in patients with driver-negative locally advanced or metastatic non-small cell lung cancer (NSCLC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Double Blind
- What is being tested?
- SCTB41, Tislelizumab and Paclitaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 410 participants
- Where
- 1 siteChina
- Study dates
- 9 May 2026to 24 Jan 2030
- Phase
- Phase 2/3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntary written informed consent (ICF) signed prior to screening.
- Age ≥18 years, male or female.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
- Expected survival ≥3 months.
- Histologically or cytologically confirmed locally advanced (Stage IIIB/IIIC) or metastatic (Stage IV) non-small cell lung cancer (NSCLC) that is not amenable to complete surgical resection and is not suitable for definitive concurrent or sequential chemoradiotherapy, according to the 9th edition of the TNM staging system by the Union for International Cancer Control (UICC) and the American Joint Committee on Cancer (AJCC).
- For subjects with adenocarcinoma, non-smokers, or squamous cell carcinoma with mixed adenocarcinoma components, absence of sensitizing EGFR mutations (e.g., exon 19 deletion, exon 21 L858R, exon 21 L861Q, exon 18 G719X, or exon 20 S768I) or ALK gene rearrangements must be confirmed by tumor tissue, cytology, or blood samples prior to enrollment.
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- Availability of tumor tissue samples for PD-L1 testing.
- No prior systemic anticancer therapy for the study disease.
- At least one measurable lesion (excluding brain lesions) per RECIST v1.1. 10 Adequate organ function.
Who cannot join
- Known ROS1 fusion-positive, BRAF V600E mutation, or other driver mutations for which guideline-recommended first-line targeted therapies are available.
- Prior thoracic radiotherapy.
- Symptomatic central nervous system metastases.
- Imaging evidence during screening showing tumor invasion of major blood vessels, invasion of critical surrounding organs, or risk of tracheoesophageal fistula or esophagopleural fistula as assessed by the investigator.
- History of hypertensive crisis or hypertensive encephalopathy, or uncontrolled hypertension despite medication.
- Active autoimmune disease or a history of autoimmune disease with a risk of recurrence.
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- Bleeding tendency, high bleeding risk, or coagulation disorders.
- Other malignancies.
- Active serious infection prior to first dose, including active infection, active tuberculosis, HIV positivity, active hepatitis B or C, or known active syphilis.
- Clinically significant pleural effusion, pericardial effusion, or ascites requiring repeated drainage.
- History of non-infectious pneumonia requiring systemic corticosteroid therapy or current interstitial lung disease.
- Prior allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.
- Known allergy to any component of the investigational drug(s), or history of severe hypersensitivity reaction to any monoclonal antibody.
- Participation in another clinical trial, except for follow-up in observational (non-interventional) studies or follow-up phases of interventional studies.
- Pregnant or breastfeeding women.
- Known alcohol or drug abuse, psychiatric disorders, or history of illicit drug use.
- Any other condition deemed unsuitable for enrollment by the investigator.
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
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, 510000
yanyan yang, medical monitor, 18353576376, yanyan_yang@sinocelltech.com
About this study
Official title: A Multicenter Phase II/III Study Evaluating the Efficacy and Safety of SCTB41 Combined With Chemotherapy Versus Tislelizumab Combined With Chemotherapy as First-Line Treatment for Driver-Negative Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)
This is a multicenter Phase II/III study evaluating the efficacy and safety of SCTB41 combined with chemotherapy versus tislelizumab combined with chemotherapy as first-line treatment in patients with driver-negative locally advanced or metastatic non-small cell lung cancer (NSCLC).
The Phase II portion is an open-label safety run-in study enrolling approximately 30-60 patients to evaluate the safety and tolerability of SCTB41 plus chemotherapy. Following confirmation of acceptable safety and preliminary efficacy, the study will proceed to the Phase III portion.
The Phase III portion is a randomized, double-blind, active-controlled study enrolling approximately 350 patients. Eligible participants will be randomized in a 1:1 ratio to receive SCTB41 plus chemotherapy or tislelizumab plus chemotherapy. The primary objective is to compare progression-free survival assessed by blinded independent central review according to RECIST version 1.1.
Read the detailed description
The Phase II portion is an open-label safety run-in study enrolling approximately 30-60 patients to evaluate the safety and tolerability of SCTB41 plus chemotherapy. Following confirmation of acceptable safety and preliminary efficacy, the study will proceed to the Phase III portion.
The Phase III portion is a randomized, double-blind, active-controlled study enrolling approximately 350 patients. Eligible participants will be randomized in a 1:1 ratio to receive SCTB41 plus chemotherapy or tislelizumab plus chemotherapy. The primary objective is to compare progression-free survival assessed by blinded independent central review according to RECIST version 1.1.
- Conditions
- Double Blind
- Being tested
- SCTB41, Tislelizumab, Paclitaxel, Nab-paclitaxel, Carboplatin
- Keywords
- Advanced Non-Small Cell Lung Cancer, Non-Small Cell Lung Cancer, SCTB41
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SCTB41Drug
IV infusion,Specified dose on specified days.
TislelizumabDrug
IV infusion,Specified dose on specified days.
PaclitaxelDrug
175 mg/m², IV infusion, Q3W, for 4 cycles.
Nab-paclitaxelDrug
100 mg/m², IV infusion, on Days 1, 8, 15 of each 3-week cycle, for 4 cycles
CarboplatinDrug
AUC 5, IV infusion, Q3W, for 4 cycles.
CisplatinDrug
75 mg/m², IV infusion, Q3W, for 4 cycles.
PemetrexedDrug
500 mg/m², IV infusion, Q3W, for 4 cycles .
| Study group | Role | What they receive |
|---|---|---|
| SCTB41 + Chemotherapy | Experimental | SCTB41 will be administered at a selected dose intravenously (IV) every three weeks (Q3W). Chemotherapy regimen will be selected by the investigator based on histological subtype: squamous NSCLC receives carboplatin + paclitaxel or nab-paclitaxel; non-squamous NSCLC receives pemetrexed + cisplatin or carboplatin. Combination therapy will be administered for 4 cycles , followed by maintenance therapy according to the protocol. Receives: Drug: SCTB41; Drug: Paclitaxel; Drug: Nab-paclitaxel; Drug: Carboplatin; Drug: Cisplatin; Drug: Pemetrexed |
| Tislelizumab + Chemotherapy | Active comparator | Tislelizumab will be administered at a dose of 200 mg intravenously (IV) every three weeks (Q3W). Chemotherapy regimen will be selected by the investigator based on histological subtype: squamous NSCLC receives carboplatin + paclitaxel or nab-paclitaxel; non-squamous NSCLC receives pemetrexed + cisplatin or carboplatin. Combination therapy will be administered for 4 cycles, followed by maintenance therapy according to the protocol. Receives: Drug: Tislelizumab; Drug: Paclitaxel; Drug: Nab-paclitaxel; Drug: Carboplatin; Drug: Cisplatin; Drug: Pemetrexed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival (PFS)
Progression-free survival (PFS) is defined as the time from the date of randomization till the first documentation of disease progression (per RECIST v1.1 criteria) assessed by the blinded IRRC or death due to any cause (whichever occurs first).
Measured: Up to approximately 24 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2026
- Study start9 May 2026
- Primary completion24 Jan 2030 (estimated)
- Study completion24 Jan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Double BlindStudies of the same condition, open and under way.
- More trials run by Sinocelltech Ltd.The 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomized in a 1:1 ratio using a stratified block design, with stratification factors of pathological type (squamous vs. non-squamous), PD-L1 expression (TPS \<1%, 1-49%, ≥50%), and tumor clinical stage (Stage III vs. Stage IV).
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 410 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sinocelltech Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07662395
- Sponsor's protocol ID
- SCTB41-A303
- Status last verified
- Jun 2026
- First submitted
- 16 Jun 2026
- Last updated
- 23 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Phase II/III Study Evaluating the Efficacy and Safety of SCTB41 Combined With Chemotherapy Versus Tislelizumab Combined With Chemotherapy as First-Line Treatment for Driver-Negative Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)
- ClinicalTrials.gov ID
- NCT07662395
- Acronym / sponsor ID
- SCTB41-A303
- Conditions
- Double Blind
- Keywords
- Advanced Non-Small Cell Lung Cancer, Non-Small Cell Lung Cancer, SCTB41
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 410 participants (estimated)
- Lead sponsor
- Sinocelltech Ltd.Industry (pharma, biotech, devices)
- Study start
- 9 May 2026 (actual)
- Primary completion
- 24 Jan 2030 (estimated)
- Study completion
- 24 Jan 2030 (estimated)
- First posted
- 23 Jun 2026 (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.
This is a multicenter Phase II/III study evaluating the efficacy and safety of SCTB41 combined with chemotherapy versus tislelizumab combined with chemotherapy as first-line treatment in patients with driver-negative locally advanced or metastatic non-small cell lung cancer (NSCLC).
The Phase II portion is an open-label safety run-in study enrolling approximately 30-60 patients to evaluate the safety and tolerability of SCTB41 plus chemotherapy. Following confirmation of acceptable safety and preliminary efficacy, the study will proceed to the Phase III portion.
The Phase III portion is a randomized, double-blind, active-controlled study enrolling approximately 350 patients. Eligible participants will be randomized in a 1:1 ratio to receive SCTB41 plus chemotherapy or tislelizumab plus chemotherapy. The primary objective is to compare progression-free survival assessed by blinded independent central review according to RECIST version 1.1.
Detailed description
The Phase II portion is an open-label safety run-in study enrolling approximately 30-60 patients to evaluate the safety and tolerability of SCTB41 plus chemotherapy. Following confirmation of acceptable safety and preliminary efficacy, the study will proceed to the Phase III portion.
The Phase III portion is a randomized, double-blind, active-controlled study enrolling approximately 350 patients. Eligible participants will be randomized in a 1:1 ratio to receive SCTB41 plus chemotherapy or tislelizumab plus chemotherapy. The primary objective is to compare progression-free survival assessed by blinded independent central review according to RECIST version 1.1.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants are randomized in a 1:1 ratio using a stratified block design, with stratification factors of pathological type (squamous vs. non-squamous), PD-L1 expression (TPS <1%, 1-49%, ≥50%), and tumor clinical stage (Stage III vs. Stage IV).
| Arm | Type | Receives |
|---|---|---|
| SCTB41 + Chemotherapy | Experimental | Drug: SCTB41, Drug: Paclitaxel, Drug: Nab-paclitaxel, Drug: Carboplatin, Drug: Cisplatin, Drug: PemetrexedSCTB41 will be administered at a selected dose intravenously (IV) every three weeks (Q3W). Chemotherapy regimen will be selected by the investigator based on histological subtype: squamous NSCLC receives carboplatin + paclitaxel or nab-paclitaxel; non-squamous NSCLC receives pemetrexed + cisplatin or carboplatin. Combination therapy will be administered for 4 cycles , followed by maintenance therapy according to the protocol. |
| Tislelizumab + Chemotherapy | Active comparator | Drug: Tislelizumab, Drug: Paclitaxel, Drug: Nab-paclitaxel, Drug: Carboplatin, Drug: Cisplatin, Drug: PemetrexedTislelizumab will be administered at a dose of 200 mg intravenously (IV) every three weeks (Q3W). Chemotherapy regimen will be selected by the investigator based on histological subtype: squamous NSCLC receives carboplatin + paclitaxel or nab-paclitaxel; non-squamous NSCLC receives pemetrexed + cisplatin or carboplatin. Combination therapy will be administered for 4 cycles, followed by maintenance therapy according to the protocol. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Voluntary written informed consent (ICF) signed prior to screening.
- Age ≥18 years, male or female.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
- Expected survival ≥3 months.
- Histologically or cytologically confirmed locally advanced (Stage IIIB/IIIC) or metastatic (Stage IV) non-small cell lung cancer (NSCLC) that is not amenable to complete surgical resection and is not suitable for definitive concurrent or sequential chemoradiotherapy, according to the 9th edition of the TNM staging system by the Union for International Cancer Control (UICC) and the American Joint Committee on Cancer (AJCC).
Key exclusion criteria (17 listed)
- Known ROS1 fusion-positive, BRAF V600E mutation, or other driver mutations for which guideline-recommended first-line targeted therapies are available.
- Prior thoracic radiotherapy.
- Symptomatic central nervous system metastases.
- Imaging evidence during screening showing tumor invasion of major blood vessels, invasion of critical surrounding organs, or risk of tracheoesophageal fistula or esophagopleural fistula as assessed by the investigator.
- History of hypertensive crisis or hypertensive encephalopathy, or uncontrolled hypertension despite medication.
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 |
|---|---|---|
| SCTB41IV infusion,Specified dose on specified days. | Drug | SCTB41 + Chemotherapy |
| TislelizumabIV infusion,Specified dose on specified days. | Drug | Tislelizumab + Chemotherapy |
| Paclitaxel175 mg/m², IV infusion, Q3W, for 4 cycles. | Drug | SCTB41 + Chemotherapy, Tislelizumab + Chemotherapy |
| Nab-paclitaxel100 mg/m², IV infusion, on Days 1, 8, 15 of each 3-week cycle, for 4 cycles | Drug | SCTB41 + Chemotherapy, Tislelizumab + Chemotherapy |
| CarboplatinAUC 5, IV infusion, Q3W, for 4 cycles. | Drug | SCTB41 + Chemotherapy, Tislelizumab + Chemotherapy |
| Cisplatin75 mg/m², IV infusion, Q3W, for 4 cycles. | Drug | SCTB41 + Chemotherapy, Tislelizumab + Chemotherapy |
| Pemetrexed500 mg/m², IV infusion, Q3W, for 4 cycles . | Drug | SCTB41 + Chemotherapy, Tislelizumab + Chemotherapy |
Primary outcome
Progression-Free Survival (PFS)
Time frame: Up to approximately 24 months.
Progression-free survival (PFS) is defined as the time from the date of randomization till the first documentation of disease progression (per RECIST v1.1 criteria) assessed by the blinded IRRC or death due to any cause (whichever occurs first).
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 23 Jun 2026.
- Individual participant dataSharing planned: No
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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 2/3 study testing SCTB41, Tislelizumab and Paclitaxel in people with Double Blind, run by Sinocelltech Ltd. 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 9 inclusion and 17 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 23 Jun 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 yanyan yang, medical monitor (+8618353576376, yanyan_yang@sinocelltech.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-Free Survival (PFS) (time frame: Up to approximately 24 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 23 Jun 2026.