Squamous-cell Non-Small-cell Lung CancerPhase 3NCT04171284
SCT-I10A or Placebo Plus Docetaxel With Previously Treated Squamous Cell Non-small Cell Lung Cancer
A Phase 3 study testing SCT-I10 and Docetaxel in people with Squamous-cell Non-Small-cell Lung Cancer, run by Sinocelltech Ltd. at 1 site in China.
Trial summary
This is a phase 3 double-blinded randomized multicenter clinical trial of SCT-I10A or placebo plus docetaxel with previously treated squamous cell non-small cell lung cancer patients. The main endpoint is to compare the overall survival (OS) of these two regimens above. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Squamous-cell Non-Small-cell Lung Cancer
- What is being tested?
- SCT-I10 and Docetaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 188 participants
- Where
- 1 siteChina
- Study dates
- 22 Oct 2019to 23 Feb 2023
- Phase
- Phase 3
- 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
- Patients should be voluntarily sign the written informed consent.
- Histologically or cytologically confirmed diagnosis of locally advanced or metastatic squamous NSCLC. Or recurrent squamous NSCLC according UICC/AJCC 8th edition.
- At least one measurable tumor lesion per RECIST 1.1 criteria. A lesion previously irradiated could be considered as a target lesion only in the condition that progression occurred at the time of 3 months after the end of radiotherapy.
- Previously treated with one platinum based regimen (including platinum and endostar regimen) and progression occur during or after treatment or unbearable treatment related adverse events.
- Progression after EGFR-TKIs in patients with driver gene mutation.
- Eastern Cooperative Oncology Group (ECOG) performance score 0 or 1.
Who cannot join
- Patient who is allergic to recombinant humanized PD-1 monoclonal antibody or the components of the drug.
- Patient who is allergic to taxane.
- Previously treated with any of the antibodies targeted on PD-1, PD-L1, PD-2, CD137, CTLA-4, T cell, co-stimulation or drugs targeted on the checkpoint signal pathway.
- Previously treated with docetaxel.
- The histopathological subtype is not squamous cell non-small cell lung cancer, or squamous cell < 90% in a mixed carcinoma.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter Randomized Double-blinded Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of SCT-I10A or Placebo Plus Docetaxel in Treating Advanced Squamous Non-small Cell Lung Cancer
This is a phase 3 double-blinded randomized multicenter clinical trial of SCT-I10A or placebo plus docetaxel with previously treated squamous cell non-small cell lung cancer patients. The main endpoint is to compare the overall survival (OS) of these two regimens above.
Read the detailed description
In 2015, there were near 787,000 patients diagnosed with lung cancer in China. And in the very same year, 631,000 lung cancer patients died of the disease. Lung cancer still causes most cancer related death in here. Approximately 85% of lung cancer is non-small cell lung cancer (NSCLC) compared with small cell lung cancer (~15%) pathologically. NSCLC include squamous cell NSCLC, adenocarcinoma and large cell carcinoma. Although there are therapies developed to treat the condition, patients with advanced squamous-cell (NSCLC) who have disease progression during or after first-line chemotherapy have limited treatment options in China. Hence, we developed a fully human IgG4 programmed death 1 (PD-1) immune-checkpoint-inhibitor monoclonal antibody (SCT-I10A) which inhibits the interaction between PD-1 and its ligands results in the reactivation of active T cell and finally leads to caner immunotherapy. We are now carrying out a phase 3 clinical trial to determine whether SCT-I10A plus docetaxel surpass docetaxel monotherapy with previously treated squamous-cell NSCLC patients. As designed in the protocol, 360 eligible subjects would be randomized into two arms in a ratio of 2:1. 240 subjects would be treated with SCT-I10A plus docetaxel in the experimental arm while 120 subjects would be treated with placebo plus docetaxel in the active comparator arm. Both of these arms will be treated with maintenance therapy after planed treatments. Our primary endpoint is overall survival, secondary endpoints are PFS, OSR, ORR, DOR, DCR and other efficacy and safety index.
- Conditions
- Squamous-cell Non-Small-cell Lung Cancer
- Being tested
- SCT-I10, Docetaxel, Placebo
- Keywords
- Non-small cell lung cancer, Squamous cell carcinoma
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Carcinoma, Squamous Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SCT-I10Drug
Also called human PD-1 monoclonal antibody
200 mg, Q3W, maximum treatment up to six cycles
DocetaxelDrug
70-75mg per square meters of body surface area, Q3W, maximum treatment up to six cycles
PlaceboDrug
200 mg, Q3W, maximum treatment up to six cycles
| Study group | Role | What they receive |
|---|---|---|
| SCT-I10A plus Docetaxel | Experimental | SCT-I10A 200mg, I.V., Q3W; Docetaxel 70-75 mg per square meters of body surface area,I.V., Q3W. Maximum of 6 cycles Receives: Drug: SCT-I10; Drug: Docetaxel |
| Placebo puls docetaxel | Active comparator | Placebo 200mg, I.V., Q3W; Docetaxel 70-75 mg per square meters of body surface area,I.V., Q3W Maximum of 6 cycles Receives: Drug: Docetaxel; Drug: Placebo |
| Maintenance therapy of SCT-I10A | Experimental | Subjects complete 2-6 cycles of combined therapies, when the evaluation result is CR, PR or SD (RECIST 1.1), the subjects will enter maintain therapy: SCT-I10A 200mg, I.V., Q3W, till progression, loss to follow-up, new antineoplastic therapy or intolerable toxicity. Receives: Drug: SCT-I10 |
| Maintenance therapy of Placebo | Placebo comparator | Subjects complete 2-6 cycles of combined therapies, when the evaluation result is CR, PR or SD (RECIST 1.1), the subjects will enter maintain therapy: Placebo 200mg, I.V., Q3W, till progression, loss to follow-up, new antineoplastic therapy or intolerable toxicity. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
OS is the time from the date of randomization to death due to any cause.
Measured: Up to approximately 3 years
Secondary outcomes (9)
PFS
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 investigator or death due to any cause (whichever occurs first).
Measured: Up to approximately 3 years
OSR of 6 months, 12 months and 18 moths
overall survival rate from the date of randomization till the 6 months,12 months and 18 months
Measured: Each subject that randomized will be followed up for 18 months to measure the OSR.
ORR
ORR is the proportion of subjects with CR or PR based on RECIST v1.1.
Measured: Up to approximately 3 years
DOR
DoR is defined as the duration from the first documentation of objective response to the first documented disease progression or death due to any cause, whichever occurs first.
Measured: Up to approximately 3 years
DCR
DCR is defined as the proportion of subjects with CR, PR, or SD based on RECIST v1.1.
Measured: Up to approximately 3 years
The concentration of anti-SCT-I10A antibodies in the serum of subjects
The concentration of anti-SCT-I10A antibodies in the serum of subjects during or after the study treatments will be measured, its level could indicate the immunogenicity of SCT-I10A.
Measured: Up to approximately 3 years
The expression level of PD-L1 of subjects' specimens
The expression level of PD-L1 of the subjects would be measure by immunohistochemical detection. The results would be used to analyze the correlation of PD-L1 level and outcomes including primary and secondary endpoints including OS, PFS, OSR, ORR, DOR and DCR.
Measured: Up to approximately 3 years
Cancer-specific quality of life of the regimens treated subjects
European Organisation for Research and Treatment of Cancer (EORTC) cancer-specific quality of life questionnaire (EORTC QLQ-C30) will be applied in all subjects to collect the score of 30 items of subjects before and after study treatments. For the items from one to twenty-eight, the minimum and maximum scores are 28 and 112 respectively and the higher score means a worse outcome. For the items from twenty-nine to thirty, the minimum and maximum raw scores are 2 and 14 respectively and the higher score means a better outcome. Further analysis could be done based on the calculation.
Measured: Up to approximately 3 years
Lung cancer-specific quality of life of the regimens treated subjects
European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Lung Cancer 13 (QLQ-LC13) will be applied in all subjects to collect the score of 13 specific typical symptoms of lung cancer patients before and after study treatments. The minimum and maximum raw scores are 12 and 52 respectively, the higher score means a worse outcome.
Measured: Up to approximately 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2019
- Study start22 Oct 2019
- Primary completion23 Feb 2023
- Study completion23 Feb 2023
Why it stopped: Strategy adjustments, independent of the safety and efficacy of the trial medication
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 Squamous-cell Non-Small-cell Lung CancerStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 188 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sinocelltech Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Han Baohui, M.D., Principal investigator, Shanghai Chest Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04171284
- Sponsor's protocol ID
- SCT-I10A-D301
- Status last verified
- Feb 2024
- First submitted
- 12 Nov 2019
- Last updated
- 9 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Han B, Wu L, Yang R, Wu H, Li W, Yu Y, Zhang M, Sun H, Chu T, Zhong F, Fang Y, Wu R, Bian T, Guo X, Sun M, Zhang Y, Liu L, Liu X, Pan Y, Jiang O, Wei Z, Lin H, Guo W, Fang J, Wang J, Ding C, Hu Y, Ye F, Zhuang W, Ye S, Wang L, Huang Z, Liu C, Yang L, Wang J, Xie L. Efficacy and safety of finotonlimab plus docetaxel vs. docetaxel in previously treated advanced squamous cell non-small-cell lung cancer: a randomized, double-blinded, phase III trial. Transl Lung Cancer Res. 2025 Apr 30;14(4):1231-1241. doi: 10.21037/tlcr-24-1042. Epub 2025 Apr 16.
PubMed 40386729
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Randomized Double-blinded Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of SCT-I10A or Placebo Plus Docetaxel in Treating Advanced Squamous Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT04171284
- Acronym / sponsor ID
- SCT-I10A-D301
- Conditions
- Squamous-cell Non-Small-cell Lung Cancer
- Keywords
- Non-small cell lung cancer, Squamous cell carcinoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Strategy adjustments, independent of the safety and efficacy of the trial medication
- Enrolment
- 188 participants (actual)
- Lead sponsor
- Sinocelltech Ltd.Industry (pharma, biotech, devices)
- Study start
- 22 Oct 2019 (actual)
- Primary completion
- 23 Feb 2023 (actual)
- Study completion
- 23 Feb 2023 (actual)
- First posted
- 20 Nov 2019 (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 phase 3 double-blinded randomized multicenter clinical trial of SCT-I10A or placebo plus docetaxel with previously treated squamous cell non-small cell lung cancer patients. The main endpoint is to compare the overall survival (OS) of these two regimens above.
Detailed description
In 2015, there were near 787,000 patients diagnosed with lung cancer in China. And in the very same year, 631,000 lung cancer patients died of the disease. Lung cancer still causes most cancer related death in here. Approximately 85% of lung cancer is non-small cell lung cancer (NSCLC) compared with small cell lung cancer (~15%) pathologically. NSCLC include squamous cell NSCLC, adenocarcinoma and large cell carcinoma. Although there are therapies developed to treat the condition, patients with advanced squamous-cell (NSCLC) who have disease progression during or after first-line chemotherapy have limited treatment options in China. Hence, we developed a fully human IgG4 programmed death 1 (PD-1) immune-checkpoint-inhibitor monoclonal antibody (SCT-I10A) which inhibits the interaction between PD-1 and its ligands results in the reactivation of active T cell and finally leads to caner immunotherapy. We are now carrying out a phase 3 clinical trial to determine whether SCT-I10A plus docetaxel surpass docetaxel monotherapy with previously treated squamous-cell NSCLC patients. As designed in the protocol, 360 eligible subjects would be randomized into two arms in a ratio of 2:1. 240 subjects would be treated with SCT-I10A plus docetaxel in the experimental arm while 120 subjects would be treated with placebo plus docetaxel in the active comparator arm. Both of these arms will be treated with maintenance therapy after planed treatments. Our primary endpoint is overall survival, secondary endpoints are PFS, OSR, ORR, DOR, DCR and other efficacy and safety index.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| SCT-I10A plus Docetaxel | Experimental | Drug: SCT-I10, Drug: DocetaxelSCT-I10A 200mg, I.V., Q3W; Docetaxel 70-75 mg per square meters of body surface area,I.V., Q3W. Maximum of 6 cycles |
| Placebo puls docetaxel | Active comparator | Drug: Docetaxel, Drug: PlaceboPlacebo 200mg, I.V., Q3W; Docetaxel 70-75 mg per square meters of body surface area,I.V., Q3W Maximum of 6 cycles |
| Maintenance therapy of SCT-I10A | Experimental | Drug: SCT-I10Subjects complete 2-6 cycles of combined therapies, when the evaluation result is CR, PR or SD (RECIST 1.1), the subjects will enter maintain therapy: SCT-I10A 200mg, I.V., Q3W, till progression, loss to follow-up, new antineoplastic therapy or intolerable toxicity. |
| Maintenance therapy of Placebo | Placebo comparator | Drug: PlaceboSubjects complete 2-6 cycles of combined therapies, when the evaluation result is CR, PR or SD (RECIST 1.1), the subjects will enter maintain therapy: Placebo 200mg, I.V., Q3W, till progression, loss to follow-up, new antineoplastic therapy or intolerable toxicity. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients should be voluntarily sign the written informed consent.
- Histologically or cytologically confirmed diagnosis of locally advanced or metastatic squamous NSCLC. Or recurrent squamous NSCLC according UICC/AJCC 8th edition.
- At least one measurable tumor lesion per RECIST 1.1 criteria. A lesion previously irradiated could be considered as a target lesion only in the condition that progression occurred at the time of 3 months after the end of radiotherapy.
- Previously treated with one platinum based regimen (including platinum and endostar regimen) and progression occur during or after treatment or unbearable treatment related adverse events.
- Progression after EGFR-TKIs in patients with driver gene mutation.
Key exclusion criteria (5 listed)
- Patient who is allergic to recombinant humanized PD-1 monoclonal antibody or the components of the drug.
- Patient who is allergic to taxane.
- Previously treated with any of the antibodies targeted on PD-1, PD-L1, PD-2, CD137, CTLA-4, T cell, co-stimulation or drugs targeted on the checkpoint signal pathway.
- Previously treated with docetaxel.
- The histopathological subtype is not squamous cell non-small cell lung cancer, or squamous cell < 90% in a mixed carcinoma.
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 |
|---|---|---|
| SCT-I10Also: human PD-1 monoclonal antibody200 mg, Q3W, maximum treatment up to six cycles | Drug | Maintenance therapy of SCT-I10A, SCT-I10A plus Docetaxel |
| Docetaxel70-75mg per square meters of body surface area, Q3W, maximum treatment up to six cycles | Drug | Placebo puls docetaxel, SCT-I10A plus Docetaxel |
| Placebo200 mg, Q3W, maximum treatment up to six cycles | Drug | Maintenance therapy of Placebo, Placebo puls docetaxel |
Primary outcome
Overall survival
Time frame: Up to approximately 3 years
OS is the time from the date of randomization to death due to any cause.
9 secondary outcomes
PFS
Time frame: Up to approximately 3 years
OSR of 6 months, 12 months and 18 moths
Time frame: Each subject that randomized will be followed up for 18 months to measure the OSR.
ORR
Time frame: Up to approximately 3 years
DOR
Time frame: Up to approximately 3 years
DCR
Time frame: Up to approximately 3 years
The concentration of anti-SCT-I10A antibodies in the serum of subjects
Time frame: Up to approximately 3 years
The expression level of PD-L1 of subjects' specimens
Time frame: Up to approximately 3 years
Cancer-specific quality of life of the regimens treated subjects
Time frame: Up to approximately 3 years
Lung cancer-specific quality of life of the regimens treated subjects
Time frame: Up to approximately 3 years
Results and safety
The study was stopped early (reason given: Strategy adjustments, independent of the safety and efficacy of the trial medication). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2024.
- Derived from this study: PubMed 40386729Han B, Wu L, Yang R, Wu H, Li W, Yu Y, Zhang M, Sun H, Chu T, Zhong F, Fang Y, Wu R, Bian T, Guo X, Sun M, Zhang Y, Liu L, Liu X, Pan Y, Jiang O, Wei Z, Lin H, Guo W, Fang J, Wang J, Ding C, Hu Y, Ye F, Zhuang W, Ye S, Wang L, Huang Z, Liu C, Yang L, Wang J, Xie L. Efficacy and safety of finotonlimab plus docetaxel vs. docetaxel in previously treated advanced squamous cell non-small-cell lung cancer: a randomized, double-blinded, phase III trial. Transl Lung Cancer Res. 2025 Apr 30;14(4):1231-1241. doi: 10.21037/tlcr-24-1042. Epub 2025 Apr 16.
- 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. This study is not recruiting at the moment.
Han Baohui, M.D. 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 3 study testing SCT-I10 and Docetaxel in people with Squamous-cell Non-Small-cell Lung Cancer, 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 6 inclusion and 5 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: stopped early, as of the sponsor's last update on 9 Feb 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. Some participants in this study may receive a placebo. 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 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?
The study was stopped early (reason given: Strategy adjustments, independent of the safety and efficacy of the trial medication). Results are not available in the source record.
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?
Overall survival (time frame: Up to approximately 3 years). 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 NCT04171284, 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 9 Feb 2024; AzTrials last refreshed its copy on 4 Nov 2026.