Lung Squamous Cell CarcinomaPhase 4NCT05782764
A Study of Endostar Combined With Chemotherapy and Immunotherapy in Lung Squamous Cell Carcinom
A Phase 4 study testing To explore the efficacy and safety of immune checkpoint inhibitor combined with endostar and chemotherapy in the treatment of advanced lung squamous cell carcinoma (stage IIIB-IV). in people with Lung Squamous Cell Carcinoma, run by Xuzhou Medical University at 1 site in China.
Trial summary
To explore the efficacy and safety of immune checkpoint inhibitor combined with endostar and chemotherapy in the treatment of advanced lung squamous cell carcinoma (stage IIIB-IV). Read more about this study
- Who is it for?
- Ages 18 to 78 years
- Conditions the study is for
- Lung Squamous Cell Carcinoma
- What is being tested?
- To explore the efficacy and safety of immune checkpoint inhibitor combined with endostar and chemotherapy in the treatment of advanced lung squamous cell carcinoma (stage IIIB-IV).
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2023to 30 May 2025
- Phase
- Phase 4
- 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 78 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Provided written informed consent before performing any trial-related procedures;
- 2. Aged from 18 to 75 years old (including 75 years old);
- 3. Patients with histologically or cytologically confirmed, locally advanced (stage IIIB/IIIC), metastatic, or recurrent (stage IV) squamous NSCLC according to the International Association for the Study of Lung Cancer and American Joint Committee on Classification of Cancer 8th Edition TNM classification of Lung cancer, who are inoperable and not amenable to definitive concurrent chemoradiotherapy;
- 4. At least one radiographic measurable lesion according to response evaluation Criteria in Solid Tumors (RECIST, version 1.1);
Who cannot join
- If the tumor had invaded large blood vessels on imaging (CT or MRI), or it was judged that the tumor was likely to invade important blood vessels and cause fatal hemorrhage during the follow-up study;
- Currently participating in an interventional clinical study treatment or receiving another study drug or study device within 4 weeks before the first dose;
- Presence of active hemoptysis, active diverticulitis, abdominal abscess, gastrointestinal obstruction, and peritoneal metastasis requiring clinical intervention;
- Grade III-IV congestive heart failure (New York Heart Association class) with poorly controlled clinically significant arrhythmias;
- Any arterial thrombosis, embolism, or ischemia, such as myocardial infarction, unstable angina pectoris, cerebrovascular accident, or transient ischemic attack, occurred within 6 months before enrollment;
- Known allergic reactions to the study drugs;
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- Patients requiring long-term systemic corticosteroids. Patients who required intermittent use of bronchodilators, inhaled corticosteroids, or topical corticosteroid injections due to COPD or asthma were eligible.
- Symptomatic central nervous system metastases Patients with asymptomatic brain metastases or symptomatic stabilization of treated brain metastases were eligible to participate in the study if they met all the following criteria: measurable disease outside the central nervous system; No metastasis was found in midbrain, pons, cerebellum, meninges, medulla oblongata or spinal cord. Maintain a clinically stable state for at least 2 weeks; Hormone therapy was stopped 3 days before the first dose of study drug;
- Active infection requiring treatment or use of systemic anti-infective agents within 1 week before the first dose;
- Has not fully recovered from any intervention-related toxicity and/or complications before starting treatment (i.e., grade ≤1 or baseline, excluding fatigue or alopecia);
- Known history of human immunodeficiency virus (HIV) infection (i.e., HIV 1/2 antibody positive);
- Untreated active hepatitis B (defined as both HBsAg positivity and HBV-DNA copies greater than the upper limit of normal in the laboratory of the participating center);
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Yancheng Clinical College of Xuzhou Medical University
Yancheng, Jiangsu, 224001
Xichao Dai, +8666696963, rosefor1110@163.com
About this study
Official title: A Single-arm, Exploratory Clinical Study of 3-day Continuous Intravenous Pump of Endostatin (Endostar) Combined With Chemotherapy and Immune Checkpoint Inhibitor in the Treatment of Advanced Lung Squamous Cell Carcinom
To explore the efficacy and safety of immune checkpoint inhibitor combined with endostar and chemotherapy in the treatment of advanced lung squamous cell carcinoma (stage IIIB-IV).
Read the detailed description
This study is a prospective, single-arm, single-center phase II study to evaluate the efficacy and safety of immune checkpoint inhibitors in combination with chemotherapy and recombinant human endostatin in patients with advanced (stage IIIB-IV) squamous non-small cell lung cancer. Patients with locally advanced stage ⅢB/ⅢC, metastatic or recurrent stage IV squamous NSCLC who were not operable and could not receive radical concurrent chemoradiotherapy were selected after signing informed consent. Eligible subjects who met the inclusion criteria were screened for immune checkpoint inhibitor combined with chemotherapy and recombinant human endostatin. After cycles 4 to 6, maintenance therapy with an immune checkpoint inhibitor and endostatin was administered until disease progression, unacceptable toxicity, withdrawal of consent, initiation of additional antineoplastic therapy, death, or other protocol-specified discontinuation of treatment, whichever occurred first.
- Conditions
- Lung Squamous Cell Carcinoma
- Being tested
- To explore the efficacy and safety of immune checkpoint inhibitor combined with endostar and chemotherapy in the treatment of advanced lung squamous cell carcinoma (stage IIIB-IV).
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
To explore the efficacy and safety of immune checkpoint inhibitor combined with endostar and chemotherapy in the treatment of advanced lung squamous cell carcinoma (stage IIIB-IV).Drug
Also called Endostar combined with immune checkpoint inhibitor and chemotherapy in the treatment of advanced lung squamous cell carcinoma (stage IIIB-IV)
immune checkpoint inhibitor combined with endostar and chemotherapy in the treatment of advanced lung squamous cell carcinoma (stage IIIB-IV).
| Study group | Role | What they receive |
|---|---|---|
| single arm | Experimental | Recombinant human endostatin (CIV72h, D1-D3, 14 tubes) was administered by continuous intravenous infusion every 3 weeks. The drug was discontinued until disease progression or intolerable side effects. Receives: Drug: To explore the efficacy and safety of immune checkpoint inhibitor combined with endostar and chemotherapy in the treatment of advanced lung squamous cell carcinoma (stage IIIB-IV). |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
Progression-free survival time
Measured: 2months ~ 10 months
ORR
objective response rate
Measured: about 10months
AE
adverse reactions
Measured: about 10months
Secondary outcomes (1)
OS
overall survival
Measured: about 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2023
- Study start1 Jun 2023 (estimated)
- Primary completion30 May 2025 (estimated)
- Study completion30 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Squamous Cell CarcinomaStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuzhou Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xichao Dai, Xuzhou Medical University
- Investigators
- Xichao Dai, Principal investigator, Yancheng Clinical College of Xuzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05782764
- Sponsor's protocol ID
- 2023-003
- Status last verified
- Mar 2023
- First submitted
- 4 Mar 2023
- Last updated
- 24 Mar 2023
- Results posted
- No
- 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 24 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-arm, Exploratory Clinical Study of 3-day Continuous Intravenous Pump of Endostatin (Endostar) Combined With Chemotherapy and Immune Checkpoint Inhibitor in the Treatment of Advanced Lung Squamous Cell Carcinom
- ClinicalTrials.gov ID
- NCT05782764
- Acronym / sponsor ID
- 2023-003
- Conditions
- Lung Squamous Cell Carcinoma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Xuzhou Medical UniversityUniversity, hospital or other
- Study start
- 1 Jun 2023 (estimated)
- Primary completion
- 30 May 2025 (estimated)
- Study completion
- 30 May 2025 (estimated)
- First posted
- 24 Mar 2023 (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.
To explore the efficacy and safety of immune checkpoint inhibitor combined with endostar and chemotherapy in the treatment of advanced lung squamous cell carcinoma (stage IIIB-IV).
Detailed description
This study is a prospective, single-arm, single-center phase II study to evaluate the efficacy and safety of immune checkpoint inhibitors in combination with chemotherapy and recombinant human endostatin in patients with advanced (stage IIIB-IV) squamous non-small cell lung cancer. Patients with locally advanced stage ⅢB/ⅢC, metastatic or recurrent stage IV squamous NSCLC who were not operable and could not receive radical concurrent chemoradiotherapy were selected after signing informed consent. Eligible subjects who met the inclusion criteria were screened for immune checkpoint inhibitor combined with chemotherapy and recombinant human endostatin. After cycles 4 to 6, maintenance therapy with an immune checkpoint inhibitor and endostatin was administered until disease progression, unacceptable toxicity, withdrawal of consent, initiation of additional antineoplastic therapy, death, or other protocol-specified discontinuation of treatment, whichever occurred first.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| single arm | Experimental | Drug: To explore the efficacy and safety of immune checkpoint inhibitor combined with endostar and chemotherapy in the treatment of advanced lung squamous cell carcinoma (stage IIIB-IV).Recombinant human endostatin (CIV72h, D1-D3, 14 tubes) was administered by continuous intravenous infusion every 3 weeks. The drug was discontinued until disease progression or intolerable side effects. |
Who may qualify
- Ages
- 18 to 78 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 1. Provided written informed consent before performing any trial-related procedures;
- 2. Aged from 18 to 75 years old (including 75 years old);
- 3. Patients with histologically or cytologically confirmed, locally advanced (stage IIIB/IIIC), metastatic, or recurrent (stage IV) squamous NSCLC according to the International Association for the Study of Lung Cancer and American Joint Committee on Classification of Cancer 8th Edition TNM classification of Lung cancer, who are inoperable and not amenable to definitive concurrent chemoradiotherapy;
- 4. At least one radiographic measurable lesion according to response evaluation Criteria in Solid Tumors (RECIST, version 1.1);
Key exclusion criteria (12 listed)
- If the tumor had invaded large blood vessels on imaging (CT or MRI), or it was judged that the tumor was likely to invade important blood vessels and cause fatal hemorrhage during the follow-up study;
- Currently participating in an interventional clinical study treatment or receiving another study drug or study device within 4 weeks before the first dose;
- Presence of active hemoptysis, active diverticulitis, abdominal abscess, gastrointestinal obstruction, and peritoneal metastasis requiring clinical intervention;
- Grade III-IV congestive heart failure (New York Heart Association class) with poorly controlled clinically significant arrhythmias;
- Any arterial thrombosis, embolism, or ischemia, such as myocardial infarction, unstable angina pectoris, cerebrovascular accident, or transient ischemic attack, occurred within 6 months before enrollment;
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 |
|---|---|---|
| To explore the efficacy and safety of immune checkpoint inhibitor combined with endostar and chemotherapy in the treatment of advanced lung squamous cell carcinoma (stage IIIB-IV).Also: Endostar combined with immune checkpoint inhibitor and chemotherapy in the treatment of advanced lung squamous cell carcinoma (stage IIIB-IV)immune checkpoint inhibitor combined with endostar and chemotherapy in the treatment of advanced lung squamous cell carcinoma (stage IIIB-IV). | Drug | single arm |
Primary outcome
PFS
Time frame: 2months ~ 10 months
Progression-free survival time
ORR
Time frame: about 10months
objective response rate
AE
Time frame: about 10months
adverse reactions
1 secondary outcome
OS
Time frame: about 30 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2023.
- 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.
Xichao Dai principal investigator
Yancheng Clinical College of Xuzhou Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing To explore the efficacy and safety of immune checkpoint inhibitor combined with endostar and chemotherapy in the treatment of advanced lung squamous cell carcinoma (stage IIIB-IV). in people with Lung Squamous Cell Carcinoma, run by Xuzhou Medical 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 4 inclusion and 12 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 24 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Contact Min Liu (+86 66696891, lmin89@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS (time frame: 2months ~ 10 months). The study lists 3 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 24 Mar 2023.