Non-small Cell Lung Cancer Stage IIIPhase 2NCT05414630
A Study of Envafolimab in Subjects With Stage III Non-Small Cell Lung Cancer
A Phase 2 study testing Envafolimab in people with Non-small Cell Lung Cancer Stage III, run by Anhui Provincial Cancer Hospital at 1 site in China.
Trial summary
This is a prospective, single arm, phase II study to evaluate the efficacy and safety of Envafolimab in subjects with locally advanced/unresectable (Stage III) non-small cell lung cancer that has not progressed after prior concurrent/sequential chemoradiotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer Stage III
- What is being tested?
- Envafolimab
- 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
- Jun 2022to Jun 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age at least 18 years.
- Have histologically confirmed locally advanced/unresectable stage III non-small cell lung cancer.
- The first dose of Envafolimab will be administered within 1-42 days (including 42 days) after concurrent/sequential chemoradiotherapy is completed.
- ECOG performance status 0-2.
- Life expectancy ≥ 12 weeks.
- Adequate organ function.
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- For female subjects of childbearing age, urine or serum pregnancy test shall be conducted 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.
- Willing to participate in this trial; fully understand and informed of this trial, and able to provide written informed consent form (ICF).
Who cannot join
- Disease progression after concurrent/sequential chemoradiotherapy.
- Has received a live vaccine within 28 days prior to the first dose of investigational product.
- Major surgical procedure (as determined by investigators) within 28 days prior to the first dose of investigational product.
- Known positive driver gene mutation, such as EGFR sensitive mutation, ALK gene translocation or ROS1 rearrangement.
- Received any antibody/drug targeting T-cell coregulatory proteins (immune checkpoints), with a washout period of less than 28 days.
- Known history of human immunodeficiency virus (HIV) infection and/or acquired immune deficiency syndrome.
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- Subjects at active phase of chronic hepatitis B or with active hepatitis C.
- History of organ transplantation.
- History of inflammatory bowel disease or active inflammatory bowel disease (for example Crohn's disease or ulcerative colitis).
- Severe allergic reaction to other monoclonal antibodies.
- Subjects with other conditions that in the investigator's opinion may influence subject's compliance or make subjects not suitable for participating in this trial.
Trial locations and contacts
1 site in 1 country.
China1 site
Anhui Provincial Cancer Hospital
Hefei, Anhui, 230031
Yue-Yin Pan, PhD, 0551-62282236, yueyinpan1965@126.com
About this study
Official title: A Prospective, Single-arm Clinical Study of Envafolimab as Consolidation Therapy in Patients With Locally Advanced/Unresectable (Stage III) Non-Small Cell Lung Cancer That Has Not Progressed After Concurrent/Sequential Chemoradiotherapy
This is a prospective, single arm, phase II study to evaluate the efficacy and safety of Envafolimab in subjects with locally advanced/unresectable (Stage III) non-small cell lung cancer that has not progressed after prior concurrent/sequential chemoradiotherapy.
Read the detailed description
Trial design: This is a single-arm, open-label trial in patients with locally advanced/unresectable (stage III) NSCLC who did not have disease progression after concurrent/sequential chemoradiotherapy to evaluate the efficacy of Envafolimab as a consolidation treatment of the efficacy and safety.
Background:The PACIFIC and GEMSTONE-301 studies have shown the efficacy of immunization as consolidation therapy in stage III NSCLC.
Patients with stage III NSCLC who did not have disease progression after at least two cycles of concurrent/sequential chemoradiotherapy (including platinum) will receive Envafolimab (300mg, Q3W, subcutaneous injection) within 1-42 days after the end of chemoradiotherapy. The maximum duration of Envafolimab treatment is 2 years.
- Conditions
- Non-small Cell Lung Cancer Stage III
- Being tested
- Envafolimab
- 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.
EnvafolimabDrug
Envafolimab: 300 mg，D1，Q3W, until PD or intolerable toxicity. The duration of treatment with Envafolimab should not exceed 2 years.
| Study group | Role | What they receive |
|---|---|---|
| Envafolimab | Experimental | Envafolimab: subcutaneous injection, 300mg, Q3W Receives: Drug: Envafolimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progress Free Survival (PFS)
Progression-free survival (PFS per RECIST 1.1) is defined as the time from the date of randomization to the first date of recorded progression or all-cause death, whichever comes first.
Measured: 24 months after the last subject participating in.
Secondary outcomes (4)
Overall Survival (OS)
OS is defined as the time from the date of randomization to the date of death due to any cause.
Measured: 24 months after the last subject participating in.
Objective Response Rate (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.
Duration of Response (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.
Percentage of Patients Alive at 24 Months (OS24)
OS24 was defined as the percentage of patients who were alive at 24 months after randomization per the Kaplan-Meier estimate of OS at 24 months.
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 posted10 Jun 2022
- Study startJun 2022 (estimated)
- Primary completionJun 2024 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell Lung Cancer Stage IIIStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anhui Provincial Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yue-Yin Pan, Anhui Provincial Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05414630
- Sponsor's protocol ID
- SMA-NSCLC-009
- Status last verified
- Jun 2022
- First submitted
- 8 Jun 2022
- Last updated
- 10 Jun 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 10 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-arm Clinical Study of Envafolimab as Consolidation Therapy in Patients With Locally Advanced/Unresectable (Stage III) Non-Small Cell Lung Cancer That Has Not Progressed After Concurrent/Sequential Chemoradiotherapy
- ClinicalTrials.gov ID
- NCT05414630
- Acronym / sponsor ID
- SMA-NSCLC-009
- Conditions
- Non-small Cell Lung Cancer Stage III
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Anhui Provincial Cancer HospitalUniversity, hospital or other
- Study start
- Jun 2022 (estimated)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 10 Jun 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, phase II study to evaluate the efficacy and safety of Envafolimab in subjects with locally advanced/unresectable (Stage III) non-small cell lung cancer that has not progressed after prior concurrent/sequential chemoradiotherapy.
Detailed description
Trial design: This is a single-arm, open-label trial in patients with locally advanced/unresectable (stage III) NSCLC who did not have disease progression after concurrent/sequential chemoradiotherapy to evaluate the efficacy of Envafolimab as a consolidation treatment of the efficacy and safety.
Background:The PACIFIC and GEMSTONE-301 studies have shown the efficacy of immunization as consolidation therapy in stage III NSCLC.
Patients with stage III NSCLC who did not have disease progression after at least two cycles of concurrent/sequential chemoradiotherapy (including platinum) will receive Envafolimab (300mg, Q3W, subcutaneous injection) within 1-42 days after the end of chemoradiotherapy. The maximum duration of Envafolimab treatment is 2 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Envafolimab | Experimental | Drug: EnvafolimabEnvafolimab: subcutaneous injection, 300mg, Q3W |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age at least 18 years.
- Have histologically confirmed locally advanced/unresectable stage III non-small cell lung cancer.
- The first dose of Envafolimab will be administered within 1-42 days (including 42 days) after concurrent/sequential chemoradiotherapy is completed.
- ECOG performance status 0-2.
- Life expectancy ≥ 12 weeks.
Key exclusion criteria (11 listed)
- Disease progression after concurrent/sequential chemoradiotherapy.
- Has received a live vaccine within 28 days prior to the first dose of investigational product.
- Major surgical procedure (as determined by investigators) within 28 days prior to the first dose of investigational product.
- Known positive driver gene mutation, such as EGFR sensitive mutation, ALK gene translocation or ROS1 rearrangement.
- Received any antibody/drug targeting T-cell coregulatory proteins (immune checkpoints), with a washout period of less than 28 days.
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 |
|---|---|---|
| EnvafolimabEnvafolimab: 300 mg，D1，Q3W, until PD or intolerable toxicity. The duration of treatment with Envafolimab should not exceed 2 years. | Drug | Envafolimab |
Primary outcome
Progress Free Survival (PFS)
Time frame: 24 months after the last subject participating in.
Progression-free survival (PFS per RECIST 1.1) is defined as the time from the date of randomization to the first date of recorded progression or all-cause death, whichever comes first.
4 secondary outcomes
Overall Survival (OS)
Time frame: 24 months after the last subject participating in.
Objective Response Rate (ORR)
Time frame: 24 months after the last subject participating in.
Duration of Response (DOR)
Time frame: 24 months after the last subject participating in.
Percentage of Patients Alive at 24 Months (OS24)
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 10 Jun 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.
1 site 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 in people with Non-small Cell Lung Cancer Stage III, run by Anhui Provincial Cancer Hospital 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 11 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 10 Jun 2022. 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 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 Yue-Yin Pan, PhD (0551-62282236, yueyinpan1965@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progress Free Survival (PFS) (time frame: 24 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 10 Jun 2022.