Carcinoma, Non-Small-Cell LungPhase 2NCT05529355
Effect and Safety of Envafolimab Combined With Endostar/S-1 in Second-line of Advanced Non-small Cell Lung Cancer
A Phase 2 study testing Envafolimab plus Endostar and S-1, Envafolimab plus Endostar and Envafolimab plus S-1 in people with Carcinoma, Non-Small-Cell Lung, run by Anhui Chest Hospital.
Trial summary
The trial was a randomized, open-label, multicenter Phase II study of patients with advanced or metastatic NSCLC who don't harbor driver genes. The aim is to explore the efficacy and safety of Envafolimab Combined With Endostar/S-1 in second-line treatment of advanced non-small cell lung cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Carcinoma, Non-Small-Cell Lung
- What is being tested?
- Envafolimab plus Endostar and S-1, Envafolimab plus Endostar and Envafolimab plus S-1
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- 18 Sep 2022to 18 Sep 2023
- 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
- All patients are histologically or cytologically confirmed stage IV non-small cell lung cancer. Genetic testing identifies no driver gene mutations.
- Male or female, age > 18 years, < 75 years.
- Patients had not received PD-L1 inhibitors in first-line treatment.
- KPS score ≥ 70 points (ECOG score 0-1 points), the expected survival ≥3 months;
- No dysfunction of major organs. EcG, liver function, renal function, and blood count tests before treatment are normal or basically normal, but must meet the following experimental results:
- Blood routine test:
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- Leukocyte WBC≥3.5×109/L; Neutrophil count (ANC) ≥ 1.5×109/L; Platelet (PLT) ≥ 80×109/L;
- Blood biochemical test:
- Total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal values; Alanine aminotransferase (ALT/SGPT) and alanine transaminases (AST/SGOT) ≤ 2.5 times the normal high value (ULN), or ≤ 5 times the upper limit of normal value in patients with liver metastases; Serum creatinine (Cr) ≤ 1.5 times the upper limit of normal values; c. Cardiac function test: 50% of the left ventricular ejection function of the heart >; 6) The subject has good compliance, and can cooperates with follow-up.
Who cannot join
- -
About this study
Official title: An Exploratory Non-randomized Controlled Trial for Effect and Safety of Envafolimab Combined With Recombinant Human Endostartin Injection/S-1 in Second-line Treatment of Advanced Non-small Cell Lung Cancer
The trial was a randomized, open-label, multicenter Phase II study of patients with advanced or metastatic NSCLC who don't harbor driver genes. The aim is to explore the efficacy and safety of Envafolimab Combined With Endostar/S-1 in second-line treatment of advanced non-small cell lung cancer.
Read the detailed description
Patients with advanced (stage IV. NSCLC), after signing informed consent, are screened to meet the admission requirements. All the candidates are not randomly placed in 3 treatment groups (which treatment regimen the patient chooses is determined by the clinical supervisor on a patient-by-case basis).
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Being tested
- Envafolimab plus Endostar and S-1, Envafolimab plus Endostar, Envafolimab plus S-1
- 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.
Envafolimab plus Endostar and S-1Drug
Also called Envafolimab combined with Recombinant Human Endostatin Injection/Tegafur,Gimeracil and Oteracil Porassium Capsules
Immunotherapy combined with chemotherapy and anti VEGFR therapy
Envafolimab plus EndostarDrug
Also called Envafolimab combined with Recombinant Human Endostatin Injection
Immunotherapy combined with anti VEGFR therapy
Envafolimab plus S-1Drug
Also called Envafolimab combined with Tegafur,Gimeracil and Oteracil Porassium Capsules
Immunotherapy combined with chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| Envafolimab plus Endostar and S-1 | Experimental | Envafolimab (300 mg subcutaneously each time, using 4-6 cycles), Recombinant Human Endostartin Injection (210 mg, d1-7 pumps, repeat every 3 weeks, using 4-6 cycles), Tegafur,Gimeracil and Oteracil Porassium Capsules (40 mg Bid, take 2 weeks stop for 1 week, use 4-6 cycles) Receives: Drug: Envafolimab plus Endostar and S-1 |
| Envafolimab plus Endostar | Active comparator | Envafolimab (300 mg subcutaneously each time, using 4-6 cycles), Recombinant Human Endostartin Injection (210 mg, d1-7 pumps, repeat every 3 weeks, using 4-6 cycles), Receives: Drug: Envafolimab plus Endostar |
| Envafolimab plus S-1 | Active comparator | Envafolimab (300 mg subcutaneously each time, using 4-6 cycles), Tegafur,Gimeracil and Oteracil Porassium Capsules (40 mg Bid, take 2 weeks stop for 1 week, use 4-6 cycles) Receives: Drug: Envafolimab plus S-1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
objective response rate(ORR)
proportion of patients with a complete response or partial response to treatment according to Response Evaluation Criteria in Solid Tumors
Measured: six weeks
Adverse events
safety
Measured: three weeks
Secondary outcomes (2)
progression-free survival(PFS)
the time from initial treatment to disease progression
Measured: six weeks
overall survival(OS)
the time from initial treatment to death from any cause
Measured: six weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2022
- Study start18 Sep 2022 (estimated)
- Primary completion18 Sep 2023 (estimated)
- Study completion18 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, Non-Small-Cell LungStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anhui Chest Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guan Maojing, Anhui Chest Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05529355
- Sponsor's protocol ID
- Z-2014-06-2201
- Status last verified
- Sep 2022
- First submitted
- 2 Sep 2022
- Last updated
- 7 Sep 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 7 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Non-randomized Controlled Trial for Effect and Safety of Envafolimab Combined With Recombinant Human Endostartin Injection/S-1 in Second-line Treatment of Advanced Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT05529355
- Acronym / sponsor ID
- Z-2014-06-2201
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Anhui Chest HospitalUniversity, hospital or other
- Study start
- 18 Sep 2022 (estimated)
- Primary completion
- 18 Sep 2023 (estimated)
- Study completion
- 18 Sep 2023 (estimated)
- First posted
- 7 Sep 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.
The trial was a randomized, open-label, multicenter Phase II study of patients with advanced or metastatic NSCLC who don't harbor driver genes. The aim is to explore the efficacy and safety of Envafolimab Combined With Endostar/S-1 in second-line treatment of advanced non-small cell lung cancer.
Detailed description
Patients with advanced (stage IV. NSCLC), after signing informed consent, are screened to meet the admission requirements. All the candidates are not randomly placed in 3 treatment groups (which treatment regimen the patient chooses is determined by the clinical supervisor on a patient-by-case basis).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Envafolimab plus Endostar and S-1 | Experimental | Drug: Envafolimab plus Endostar and S-1Envafolimab (300 mg subcutaneously each time, using 4-6 cycles), Recombinant Human Endostartin Injection (210 mg, d1-7 pumps, repeat every 3 weeks, using 4-6 cycles), Tegafur,Gimeracil and Oteracil Porassium Capsules (40 mg Bid, take 2 weeks stop for 1 week, use 4-6 cycles) |
| Envafolimab plus Endostar | Active comparator | Drug: Envafolimab plus EndostarEnvafolimab (300 mg subcutaneously each time, using 4-6 cycles), Recombinant Human Endostartin Injection (210 mg, d1-7 pumps, repeat every 3 weeks, using 4-6 cycles), |
| Envafolimab plus S-1 | Active comparator | Drug: Envafolimab plus S-1Envafolimab (300 mg subcutaneously each time, using 4-6 cycles), Tegafur,Gimeracil and Oteracil Porassium Capsules (40 mg Bid, take 2 weeks stop for 1 week, use 4-6 cycles) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- All patients are histologically or cytologically confirmed stage IV non-small cell lung cancer. Genetic testing identifies no driver gene mutations.
- Male or female, age > 18 years, < 75 years.
- Patients had not received PD-L1 inhibitors in first-line treatment.
- KPS score ≥ 70 points (ECOG score 0-1 points), the expected survival ≥3 months;
- No dysfunction of major organs. EcG, liver function, renal function, and blood count tests before treatment are normal or basically normal, but must meet the following experimental results:
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Envafolimab plus Endostar and S-1Also: Envafolimab combined with Recombinant Human Endostatin Injection/Tegafur,Gimeracil and Oteracil Porassium CapsulesImmunotherapy combined with chemotherapy and anti VEGFR therapy | Drug | Envafolimab plus Endostar and S-1 |
| Envafolimab plus EndostarAlso: Envafolimab combined with Recombinant Human Endostatin InjectionImmunotherapy combined with anti VEGFR therapy | Drug | Envafolimab plus Endostar |
| Envafolimab plus S-1Also: Envafolimab combined with Tegafur,Gimeracil and Oteracil Porassium CapsulesImmunotherapy combined with chemotherapy | Drug | Envafolimab plus S-1 |
Primary outcome
objective response rate(ORR)
Time frame: six weeks
proportion of patients with a complete response or partial response to treatment according to Response Evaluation Criteria in Solid Tumors
Adverse events
Time frame: three weeks
safety
2 secondary outcomes
progression-free survival(PFS)
Time frame: six weeks
overall survival(OS)
Time frame: six weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Envafolimab plus Endostar and S-1, Envafolimab plus Endostar and Envafolimab plus S-1 in people with Carcinoma, Non-Small-Cell Lung, run by Anhui Chest Hospital.
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 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 7 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
objective response rate(ORR) (time frame: six weeks). The study lists 2 primary outcomes in all. 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 7 Sep 2022.