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AzTrials

Non-small Cell Lung CancerPhase 3NCT06123754

Phase III Study of Envafolimab Versus Placebo Plus Chemotherapy in Resectable Stage III NSCLC

A Phase 3 study testing Envalfolimab subcutaneously injected+Platinum-based doublet chemotherapy intravenous injection in people with Non-small Cell Lung Cancer, run by 3D Medicines (Sichuan) Co., Ltd. at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This is a randomized, controlled, double-blind, multicenter Phase 3 clinical study to assess the efficacy and safety of envafolimab plus platinum-based doublet chemotherapy versus placebo plus platinum-based doublet chemotherapy as neoadjuvant/adjuvant therapy in subjects with resectable stage IIIA and IIIB (N2)… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-small Cell Lung Cancer
What is being tested?
Envalfolimab subcutaneously injected+Platinum-based doublet chemotherapy intravenous injection
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
390 participants
Where
1 siteChina
Study dates
17 Nov 2023to 30 Dec 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

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

  • Volunteer to participate and sign the informed consent form.
  • Age ≥ 18 years old, regardless of gender.
  • Histological and/or cytological diagnosis of resectable stage IIIA-IIIB (N2) NSCLC.
  • Measurable lesions based on the response evaluation criteria in solid tumors version 1.1（RECIST 1.1）.
  • Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
  • Subjects should provide tumor tissue for detection of PD-L1 expression level.
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  • Sufficient organ and bone marrow function.
  • Expected survival ≥6 months.
  • The surgeon assessed that total lung function is able to withstand the proposed pneumonectomy procedure.

Who cannot join

  • Tumor histologically or cytologically confirmed or combined with neuroendocrine carcinoma components, or sarcomatous/sarcomatoid lesions, or adenosquamous carcinoma, or special pathological types.
  • Previous treatment with another drug that targets T cell receptors (e.g. CTLA-4, OX-40, etc.);
  • Participants with known EGFR mutation or ALK translocation, and non-squamous cell carcinoma subjects need to identify EGFR and ALK mutation status;
  • Upper lung sulcus tumor or locally advanced unresectable or metastatic disease.
  • Previous anti-tumor therapy for the disease.
  • Subjects with known or suspected interstitial pneumonia.Radiation pneumonia or other moderate to severe lung disease that may interfere with the detection or management of drug-related pulmonary toxicity and seriously affect respiratory function.
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  • Any serious active infection.
  • With uncontrolled or significant cardiovascular and cerebrovascular disease.
  • Active autoimmune disease requiring systemic treatment.
  • Immunosuppressant or systemic hormone therapy (dose >10 mg/ day prednisone or other therapeutic hormone) for immunosuppression within 14 days prior to randomization.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Changli Wang contact

0086-22-2340123

Wangchangli@tjmuch.com

China1 site, 1 recruiting

  • Tianjin cancer hospital

    Tianjin, Tianjin Municipality, 300060

    Changli Wang, 0086-22-2340123, Wangchangli@tjmuch.com

    Recruiting

Other trials in China

About this study

Official title: A Randomized, Controlled, Double-blind, Multicenter Phase III Clinical Study of Envafolimab Plus Platinum-based Doublet Chemotherapy Versus Placebo Plus Platinum-based Doublet Chemotherapy in Patients With Non-small Cell Lung Cancer

This is a randomized, controlled, double-blind, multicenter Phase 3 clinical study to assess the efficacy and safety of envafolimab plus platinum-based doublet chemotherapy versus placebo plus platinum-based doublet chemotherapy as neoadjuvant/adjuvant therapy in subjects with resectable stage IIIA and IIIB (N2) NSCLC. Primary study endpoints are MPR rate assessed by BIPR and EFS assessed by BIRC.

Read the detailed description

A total of approximately 390 participants are planned to be enrolled in this study. After being screened and qualified, the subjects will be randomly assigned to receive Envalfolimab or placebo plus platinum-based doublet chemotherapy in 1:1 ratio for a total of 3-4 cycles of neoadjuvant therapy (determined by the investigator), the feasibility of surgery is evaluated by the investigator within 4-6 weeks after the end of neoadjuvant therapy and surgery will be performed. Envafolimab (experimental group) or placebo (control group) will be administered after surgery. After completion of treatment, subjects will enter a follow-up phase, including safety follow-up, tumor disease follow-up, and survival follow-up.All randomized subjects in this study are required to receive tumor imaging evaluation as scheduled and get continuous safety assessment during the srceening and treatment period.

Being tested
Envalfolimab subcutaneously injected+Platinum-based doublet chemotherapy intravenous injection, placebo subcutaneously injected +Platinum-based doublet chemotherapy intravenous injection
Keywords
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.

  • Envalfolimab subcutaneously injected+Platinum-based doublet chemotherapy intravenous injectionDrug

    Also called Experimental

    The subjects receive Envafolimab/placebo treatment with a dosage of 600 mg/3 ml subcutaneously injected every 3 weeks.It will last about 3-4 cycles before surgery and 16 cycles after surgery.

  • placebo subcutaneously injected +Platinum-based doublet chemotherapy intravenous injectionDrug

    Also called Active Comparator

    The subjects received platinum-based doublet chemotherapy on day 1 of every cycle. It's 3 weeks per cycle and lasts 3-4 cycles before surgery.

Study groups in NCT06123754
Study groupRoleWhat they receive
Envalfolimab plus platinum-based doublet chemotherapyExperimentalEnvalfolimab plus platinum-based doublet chemotherapy for a total of 3-4 cycles of neoadjuvant therapy (determined by the investigator), Envafolimab will be administered after surgery at 600 mg every 3 weeks(Q3W) for 16 cycles at most.
Receives: Drug: Envalfolimab subcutaneously injected+Platinum-based doublet chemotherapy intravenous injection
Placebo plus platinum-based doublet chemotherapyActive comparatorPlacebo plus platinum-based doublet chemotherapy for a total of 3-4 cycles of neoadjuvant therapy (determined by the investigator), placebo will be administered after surgery every 3 weeks(Q3W) for 16 cycles at most.
Receives: Drug: placebo subcutaneously injected +Platinum-based doublet chemotherapy intravenous injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. MPR by BIPR

    MPR rate is defined as the percentage of participants having ≤10% viable tumor cells in the resected primary tumor and all resected lymph nodes following completion of neoadjuvant therapy (evaluated by BIPR)

    Measured: Up to 5 years

  2. EFS by BIRC

    EFS is defined as the time from randomization until the occurrence of events leading to inoperable disease progression, post-operative disease progression (BIRC assessment based on RECIST 1.1) or recurrence/metastasis, or death from any cause.

    Measured: Up to 5 years

Secondary outcomes (7)

  1. pCR

    pCR rate is defined as the percentage of participants having an absence of residual invasive cancer in resected lung specimens and lymph nodes following completion of neoadjuvant therapy, assessed by BIPR;

    Measured: Up to 5 years

  2. DFS

    DFS is defined as the time from post-surgery to radiographic disease progression, local or distant recurrence, or death from any cause, assessed by BIRC;

    Measured: Up to 5 years

  3. OS

    OS is defined as the time from randomization until death from any cause.;

    Measured: Up to 5 years

  4. EFS

    EFS is defined as the time from randomization until the occurrence of events leading to inoperable disease progression, post-operative disease progression or recurrence/metastasis, or death from any cause., assessed by investigator;

    Measured: Up to 5 years

  5. Explore the quality of life for subjects by EORTC QLQ-C30

    All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level.

    Thus a high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems.

    Measured: Up to 5 years

  6. Explore the quality of life for subjects by EORTC QLQ-LC13

    All of the scales and single-item measures range in score from 0 to 100. A high score for the scales and single items represents a high level of symptomatology or problems.

    Measured: Up to 5 years

  7. PD-L1, ctDNA

    To explore the correlation between clinical efficacy and tumor tissue sample biomarkers (such as PD-L1 level, etc.) and blood sample biomarkers (such as ctDNA level, etc.)

    Measured: Up to 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Nov 2023
  2. Study start17 Nov 2023
  3. Primary completion30 Dec 2027 (estimated)
  4. Study completion30 Dec 2027 (estimated)

Resources

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
Model description
This study is a randomized, controlled, double-blind, multicenter phase Ⅲ study
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
390 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06123754
Sponsor's protocol ID
KN035-CN-017
Status last verified
Mar 2026
First submitted
25 Oct 2023
Last updated
25 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Envalfolimab subcutaneously injected+Platinum-based doublet chemotherapy intravenous injection in people with Non-small Cell Lung Cancer, run by 3D Medicines (Sichuan) Co., 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 9 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 25 Mar 2026. 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 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Changli Wang (0086-22-2340123, Wangchangli@tjmuch.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

MPR by BIPR (time frame: Up to 5 years). 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?

On the ClinicalTrials.gov record for NCT06123754.

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 25 Mar 2026.

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