Squamous Non-small Cell Lung CancerPhase 2NCT05243355
Envafolimab Combined With Chemotherapy and Recombinant Human Endostatin in the First-line Treatment of Sq-NSCLC
A Phase 2 study testing "Envafolimab" and "Chemotherapy" and "Recombinant Human Endostatin" in people with Squamous Non-small Cell Lung Cancer, run by Qilu Hospital of Shandong University at 2 sites in China.
Trial summary
This is a prospective, single arm, multicenter phase II study aimed at evaluating the efficacy and safety of Envafolimab combined with standard platinum containing dual drug chemotherapy and Recombinant Human Endostatin in patients with advanced (stage IIIB-IV) squamous non-small cell lung cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Squamous Non-small Cell Lung Cancer
- What is being tested?
- "Envafolimab" and "Chemotherapy" and "Recombinant Human Endostatin"
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 2 sitesChina
- Study dates
- 3 Dec 2021to 3 Dec 2024
- 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
- Signed written informed consent；
- Aged 18-75 years old；
- Histologically or cytologically confirmed, locally advanced (Stage IIIB/C) not amenable to curative surgery or radiotherapy, or metastatic/recurrent (Stage IV) squamous NSCLC according to American Joint Committee on Cancer, 8th Edition；
- At least 1 measurable lesion as defined by RECIST v1.1；
- ECOG performance status 0-1；
- No systematic antitumor treatment for advanced / metastatic diseases has been received in the past；
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- Life expectancy sup 3 months；
- Adequate organ function；
- For female subjects of childbearing age, urine or serum pregnancy test shall be conducted 3 days before receiving the first study drug administration, and the result is negative；
- The subject and the subject's sexual partner need to use a medically approved contraceptive measure during the study treatment period and within 6 months after the end of the study treatment period.
Who cannot join
- Histology was non squamous cell NSCLC. Mixed cell types must distinguish the dominant cell morphology (squamous cell carcinoma components > 50% can be included in the group); If there are small cell carcinoma, neuroendocrine carcinoma and sarcoma, they can not be included in the group;
- EGFR sensitive mutations or ALK rearrangements;
- Imaging (CT or MRI) showed that the tumor invaded large blood vessels or it was judged that the tumor was very likely to invade important blood vessels and cause fatal bleeding during the follow-up study;
- Concurrent participation in another clinical trial;
- Have previously received the following therapies: anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs or drugs that stimulate or co inhibit T cell receptors (e.g., CTLA-4, OX-40, CD137);
- Received Chinese patent medicine with anti-tumor indications or drugs with immunomodulatory effect (thymosin, interferon, interleukin, etc.) within 2 weeks, or major surgical treatment within 3 weeks before the first administration;
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- There are active hemoptysis, active diverticulitis, abdominal abscess, gastrointestinal obstruction and peritoneal metastasis that need clinical intervention;
- Grade III-IV congestive heart failure (New York Heart Association classification), poorly controlled and clinically significant arrhythmia;
- 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 PD-1/L1 monoclonal antibodies, taxanes, cisplatin or carboplatin, recombinant human endostatin active ingredients and or any excipients;
- Patients requiring long-term systemic use of corticosteroids;
- Symptomatic central nervous metastasis;
- Active infection requiring treatment or systemic anti infective drugs used within one week before the first administration;
- Not fully recovered from toxicity and/or complications caused by any intervention before starting treatment (i.e. ≤ grade 1 or reaching baseline, excluding fatigue or hair loss);
- Known HIV infection;
- Untreated active hepatitis B (defined as HBsAg positive and HBV-DNA copy number detected greaterthan the upper limit of normal value in the laboratory of the research center);
- Active HCV infected;
- Live vaccine was administered within 30 days before the first administration;
- Pregnant or lactating women;
- Medical history or disease evidence, abnormal treatment or laboratory test values that may interfere with the test results, prevent the subjects from participating in the whole study, or other situations that the researchers believe are not suitable for inclusion.
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
Qilu hospital of Shandong univertisy
Jinan, Shandong, 250012
Lian Liu, Doctor
Lian Liu, Doctor
- Not yet recruiting
Shandong Cancer Hospital
Jinan
Jie Liu, Doctor
Jie Liu, Doctor
About this study
Official title: A Prospective, Single-arm, Phase II Study of Envafolimab Combined With Chemotherapy and Recombinant Human Endostatin in the First-line Treatment of Advanced (Stage IIIB-IV) Squamous Non-small Cell Lung Cancer
This is a prospective, single arm, multicenter phase II study aimed at evaluating the efficacy and safety of Envafolimab combined with standard platinum containing dual drug chemotherapy and Recombinant Human Endostatin in patients with advanced (stage IIIB-IV) squamous non-small cell lung cancer.
- Conditions
- Squamous Non-small Cell Lung Cancer
- Being tested
- "Envafolimab" and "Chemotherapy" and "Recombinant Human Endostatin"
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"Envafolimab" and "Chemotherapy" and "Recombinant Human Endostatin"Drug
Envafolimab: 300 mg，D1，Q3W,until PD or intolerable toxicity Chemotherapy: Paclitaxel / NAB-Paclitaxel, 175 / 260mg / m2, D1, Q3w; Cisplatin: 75mg / m2, 1-3 days, or carboplatin: AUC 5, D1, Q3w, 4-6 cycles in total.
Recombinant Human Endostatin：210mg，CIV 72h，d1-3，Q3W，4-6 cycles in total.
| Study group | Role | What they receive |
|---|---|---|
| "Envafolimab" and "Chemotherapy" and "Recombinant Human Endostatin" | Experimental | Envafolimab: 300 mg，D1，Q3W, until PD or intolerable toxicity. Paclitaxel / NAB-Paclitaxel, 175 / 260mg / m2, D1, Q3w. Cisplatin: 75mg / m2, 1-3 days, or carboplatin: AUC 5, D1, Q3w, 4-6 cycles. Recombinant Human Endostatin：210mg，CIV 72h，d1-3，Q3W，4-6 cycles in total. Receives: Drug: "Envafolimab" and "Chemotherapy" and "Recombinant Human Endostatin" |
What is being measured
The primary outcome is the main question the study is designed to answer.
1 year PFS rate
12-month progression free survival in ITT population
Measured: 12 months after the last subject participating in
Secondary outcomes (4)
ORR
The proportion of subjects with complete response (CR) and partial response (PR) in total subjects
Measured: 24 months after the last subject participating in
DOR
DoR (per RECIST 1.1) is defined as the time from the date for first documented response of complete response (CR) or partial response (PR) to the date of first documented of disease progression or death, whichever occurs first.
Measured: 24 months after the last subject participating in
PFS
Progression-free survival (PFS 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
Measured: 24 months after the last subject participating in
OS
OS is defined as the time from the starting date of study drug to the date of death due to any cause.
Measured: 24 months after the last subject participating in
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2022
- Study start3 Dec 2021
- Primary completion3 Dec 2023 (estimated)
- Study completion3 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Squamous Non-small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Qilu Hospital of Shandong 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Hospital of Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05243355
- Sponsor's protocol ID
- SMA-NSCLC-005
- Status last verified
- Dec 2021
- First submitted
- 16 Dec 2021
- Last updated
- 17 Feb 2022
- 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 17 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-arm, Phase II Study of Envafolimab Combined With Chemotherapy and Recombinant Human Endostatin in the First-line Treatment of Advanced (Stage IIIB-IV) Squamous Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT05243355
- Acronym / sponsor ID
- SMA-NSCLC-005
- Conditions
- Squamous Non-small Cell Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Qilu Hospital of Shandong UniversityUniversity, hospital or other
- Study start
- 3 Dec 2021 (actual)
- Primary completion
- 3 Dec 2023 (estimated)
- Study completion
- 3 Dec 2024 (estimated)
- First posted
- 17 Feb 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.
This is a prospective, single arm, multicenter phase II study aimed at evaluating the efficacy and safety of Envafolimab combined with standard platinum containing dual drug chemotherapy and Recombinant Human Endostatin in patients with advanced (stage IIIB-IV) squamous non-small cell lung cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| "Envafolimab" and "Chemotherapy" and "Recombinant Human Endostatin" | Experimental | Drug: "Envafolimab" and "Chemotherapy" and "Recombinant Human Endostatin"Envafolimab: 300 mg，D1，Q3W, until PD or intolerable toxicity. Paclitaxel / NAB-Paclitaxel, 175 / 260mg / m2, D1, Q3w. Cisplatin: 75mg / m2, 1-3 days, or carboplatin: AUC 5, D1, Q3w, 4-6 cycles. Recombinant Human Endostatin：210mg，CIV 72h，d1-3，Q3W，4-6 cycles in total. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Signed written informed consent；
- Aged 18-75 years old；
- Histologically or cytologically confirmed, locally advanced (Stage IIIB/C) not amenable to curative surgery or radiotherapy, or metastatic/recurrent (Stage IV) squamous NSCLC according to American Joint Committee on Cancer, 8th Edition；
- At least 1 measurable lesion as defined by RECIST v1.1；
- ECOG performance status 0-1；
Key exclusion criteria (20 listed)
- Histology was non squamous cell NSCLC. Mixed cell types must distinguish the dominant cell morphology (squamous cell carcinoma components > 50% can be included in the group); If there are small cell carcinoma, neuroendocrine carcinoma and sarcoma, they can not be included in the group;
- EGFR sensitive mutations or ALK rearrangements;
- Imaging (CT or MRI) showed that the tumor invaded large blood vessels or it was judged that the tumor was very likely to invade important blood vessels and cause fatal bleeding during the follow-up study;
- Concurrent participation in another clinical trial;
- Have previously received the following therapies: anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs or drugs that stimulate or co inhibit T cell receptors (e.g., CTLA-4, OX-40, CD137);
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" and "Chemotherapy" and "Recombinant Human Endostatin"Envafolimab: 300 mg，D1，Q3W,until PD or intolerable toxicity Chemotherapy: Paclitaxel / NAB-Paclitaxel, 175 / 260mg / m2, D1, Q3w; Cisplatin: 75mg / m2, 1-3 days, or carboplatin: AUC 5, D1, Q3w, 4-6 cycles in total. Recombinant Human Endostatin：210mg，CIV 72h，d1-3，Q3W，4-6 cycles in total. | Drug | "Envafolimab" and "Chemotherapy" and "Recombinant Human Endostatin" |
Primary outcome
1 year PFS rate
Time frame: 12 months after the last subject participating in
12-month progression free survival in ITT population
4 secondary outcomes
ORR
Time frame: 24 months after the last subject participating in
DOR
Time frame: 24 months after the last subject participating in
PFS
Time frame: 24 months after the last subject participating in
OS
Time frame: 24 months after the last subject participating in
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2022.
- 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing "Envafolimab" and "Chemotherapy" and "Recombinant Human Endostatin" in people with Squamous Non-small Cell Lung Cancer, run by Qilu Hospital of Shandong University at 2 sites 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 10 inclusion and 20 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 17 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lian Liu, Doctor (18560082903, tounao@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1 year PFS rate (time frame: 12 months after the last subject participating in). 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 Feb 2022.