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Lung Squamous Cell CarcinomaPhase 3NCT07831863

A Study of 7MW3711 Compared With Docetaxel in Advanced Squamous NSCLC After Prior Chemoimmunotherapy

A Phase 3 study testing 7MW3711 and Docetaxel in people with Lung Squamous Cell Carcinoma, run by Mabwell (Shanghai) Bioscience Co., Ltd. at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

To compare the efficacy and safety of 7MW3711 versus docetaxel in patients with locally advanced or metastatic squamous non-small cell lung cancer (sqNSCLC) . Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Lung Squamous Cell Carcinoma
What is being tested?
7MW3711 and Docetaxel
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
600 participants
Where
1 siteChina
Study dates
Oct 2026to Dec 2029
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 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • All trial participants or their legally acceptable representatives must sign the Ethics Committee-approved informed consent form before any screening procedures are initiated.
  • Aged 18 to 85 years (inclusive) at the time of signing the informed consent, regardless of gender.
  • ECOG performance status of 0 to 1.
  • Histologically or cytologically confirmed unresectable locally advanced or metastatic squamous non-small cell lung cancer (NSCLC). Mixed pathology including small cell lung cancer or other pathological components must be excluded.
  • Must have received prior first-line systemic anti-tumor therapy, including: a) platinum-based doublet chemotherapy; b) immunotherapy (including but not limited to monoclonal antibodies targeting PD-1, PD-L1, CTLA-4, or their bispecific antibodies).
  • Radiologically confirmed disease progression during or within 6 months after discontinuation of the most recent treatment regimen.
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  • Archived tumor tissue samples must be provided.
  • Expected survival of ≥ 3 months.
  • At least one measurable lesion per RECIST v1.1 criteria at screening. For those with a clear history of radiotherapy, measurable lesions must be outside the radiation field or have shown clear progression after completion of radiotherapy.
  • Organ function of trial participants must meet certain criteria.
  • Subjects with reproductive potential must take effective contraceptive measures during the trial and for 180 days after the last dose. Female subjects must be confirmed non-pregnant before enrollment, and lactating females must stop breastfeeding, unless surgically sterilized, postmenopausal, or without reproductive potential.
  • Able to understand and comply with planned visits, treatment, laboratory tests, and other study procedures.

Who cannot join

  • Received radiotherapy, chemotherapy, or other anti-tumor treatments within 21 days before the first dose; received anti-tumor traditional Chinese medicine within 7 days; received other investigational drugs or devices not yet on the market within 28 days; previously received antibody-drug conjugates (ADCs) or docetaxel.
  • Positive for clinically significant driver gene mutations, including EGFR, KRAS, ALK, ROS1, BRAF, NTRK, MET, RET, HER2.
  • Persistent clinically significant toxicities of Grade ≥ 2 related to prior therapy (excluding alopecia and Grade 2 immune-related endocrine toxicities requiring stable doses of replacement therapy).
  • Trial participants with clinically symptomatic effusions requiring local therapy or repeated drainage (pleural effusion, ascites, pericardial effusion, etc.).
  • Underwent major surgery within 28 days before the first dose of study drug, excluding minor surgeries judged by the investigator as not affecting participation in the trial.
  • Received live vaccines within 28 days before the first dose of study drug, or plan to receive any live vaccines during the study period.
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  • Clinically significant cardiovascular or cerebrovascular diseases within 6 months before the first study drug administration, including but not limited to: acute myocardial infarction, unstable angina, cerebrovascular accident, clinically significant ventricular arrhythmia, NYHA Class III/IV heart failure, QTcF ≥ 470 ms (female) / 450 ms (male), history of long QT syndrome, LVEF < 50% or severe wall motion abnormality, uncontrolled hypertension (systolic blood pressure > 160 mmHg or diastolic blood pressure > 100 mmHg), or other unsuitable arrhythmias.
  • History of pulmonary disease requiring steroid therapy; active pulmonary tuberculosis within 1 year before the first study drug administration; pulmonary embolism, severe asthma, or severe chronic obstructive pulmonary disease within 3 months; autoimmune or inflammatory diseases involving the lungs; history of prior pneumonectomy on one side.
  • History of gastrointestinal perforation or fistula within 6 months before the first study drug administration, or active gastric/duodenal ulcer, ulcerative colitis, or other gastrointestinal diseases that the investigator considers may cause bleeding or perforation.
  • Uncontrolled active bleeding or known bleeding tendency. If imaging shows tumor invasion of major blood vessels or unclear boundaries, or if the investigator judges that the tumor is highly likely to invade important blood vessels during the subsequent study period causing fatal massive bleeding.
  • History of deep vein thrombosis, pulmonary embolism, or any other severe thromboembolic event within 3 months before the first study drug administration; portal vein tumor thrombus involving both the main trunk and bilateral first-order branches, or involving both the main trunk and superior mesenteric vein, or inferior vena cava tumor thrombus.
  • Presence of any of the following infections: ① Hepatitis B virus; ② Hepatitis C virus; ③ Human immunodeficiency virus; ④ Active Mycobacterium tuberculosis infection; ⑤ Other active infections requiring systemic intravenous anti-infective treatment occurring within 14 days before the first study drug administration; ⑥ Active syphilis infection.
  • Subjects with central nervous system (CNS) metastases and/or carcinomatous meningitis. Subjects who have received treatment for brain metastases or have small, asymptomatic, incidental, untreated lesions may be considered for participation, provided that clinical symptoms are stable for at least 4 weeks before study drug administration, no disease progression is confirmed by imaging within 4 weeks before the first dose, all neurological symptoms have completely resolved, no evidence of new or enlarged brain metastases, and radiation, surgery, or steroid therapy was discontinued at least 28 days before the first dose of study treatment. Carcinomatous meningitis and meningeal compression should be excluded regardless of clinical stability.
  • Other malignancies within 3 years before the first dose of study drug, except for cured cancers.
  • Active autoimmune diseases within 6 months before the first dose of study drug. Subjects with hypothyroidism requiring only stable doses of replacement therapy or skin diseases not requiring systemic treatment are eligible.
  • Use of systemic immunosuppressive agents within 2 weeks before the first dose of study drug, excluding: topical glucocorticoids, physiological doses of systemic glucocorticoids, or glucocorticoids used as prophylaxis for hypersensitivity reactions.
  • Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.
  • History of drug abuse or psychiatric illness, or suspected allergy or intolerance to the study drug or any of its components.
  • Other conditions judged by the investigator as unsuitable for participation in the study.

Trial locations and contacts

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

Shun Lu, Doctor contact

021-22200000 ext. 3121

shun_lu@hotmail.com

China1 site

  • Shanghai Chest Hospital

    Shanghai, Shanghai Municipality, 200043

    Shun Lu, Doctor, 021-22200000 ext. 3121, shun_lu@hotmail.com

Other trials in China

About this study

Official title: A Phase III, Open-label, Randomized-controlled, Multi-center Study of 7MW3711 Compared With Docetaxel in Patients With Locally Advanced or Metastatic Squamous Non-small Cell Lung Cancer Previously Treated With Platinum-based Chemotherapy and Immunotherapy

To compare the efficacy and safety of 7MW3711 versus docetaxel in patients with locally advanced or metastatic squamous non-small cell lung cancer (sqNSCLC) .

Read the detailed description

A Phase III, Open-label, Randomized-controlled, Multi-center Study to Evaluate the Safety and Efficacy of 7MW3711 Compared with Docetaxel in Patients with Locally Advanced or Metastatic Squamous Non-small Cell Lung Cancer Previously Treated with Platinum-based Chemotherapy and Immunotherapy.

Being tested
7MW3711, Docetaxel

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 7MW3711Drug

    Participants will receive intravenous (IV) infusion of 7MW3711 as per protocol

  • DocetaxelDrug

    Participants will receive intravenous (IV) infusion of Docetaxel as per protocol

Study groups in NCT07831863
Study groupRoleWhat they receive
7MW3711ExperimentalParticipants will receive intravenous (IV) infusion of 7MW3711 as per protocol
Receives: Drug: 7MW3711
DocetaxelActive comparatorParticipants will receive intravenous (IV) infusion of Docetaxel as per protocol
Receives: Drug: Docetaxel

What is being measured

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

  1. Overall Survival

    Time from the date of randomization until the date of death from any cause.

    Measured: Up to 34 months

Secondary outcomes (10)

  1. Objective Response Rate per investigator

    The percentage of subjects who experience a best response of either CR or PR.

    Measured: Up to 34 months

  2. Progression Free Survival per investigator

    Time from the date of first randomization to the earliest date of documented disease progression per radiological evidence or death from any cause.

    Measured: Up to 34 months

  3. Duration of Response per investigator

    Time from the date of the first complete response (CR) or partial response (PR) to the earliest date of disease progression or death from any cause.

    Measured: Up to 34 months

  4. Disease Control Rate per investigator

    The percentage of subjects who experience a best response of CR, PR or stable disease (SD).

    Measured: Up to 34 months

  5. Time to response per investigator

    Time from the date of randomization to the date of CR or PR.

    Measured: Up to 34 months

  6. Incidence of adverse events

    Adverse events will be assessed by investigator(s) according to NCI-CTCAE v6.0

    Measured: Up to 34 months

  7. SAE（Serious adverse event）

    Adverse events will be assessed by investigator(s) according to NCI-CTCAE v6.0

    Measured: Up to 34 months

  8. Immunogenicity of 7MW3711

    Incidence of anti-7MW3711 anti-drug antibodies (ADAs) and/or neutralizing antibodies (NAbs)

    Measured: Up to 34 months

  9. Quality of life (QoL) assessed by EORTC QLQ-C30

    Quality of life (QoL) assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). The EORTC QLQ-C30 consists of functional scales, symptom scales, and a global health status scale. All scores are linearly transformed to a 0 to 100 scale. For functional scales and global health status, higher scores indicate a better outcome (better functioning/quality of life). For symptom scales, higher scores indicate a worse outcome (more severe symptoms).

    Measured: Up to 34 months

  10. Quality of life (QoL) assessed by EQ-5D-5L

    Quality of life (QoL) assessed by the EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L). The EQ-5D-5L consists of a descriptive system (which can be converted into a utility index score) and a visual analogue scale (EQ VAS). The utility index score typically ranges from 0 to 1, where 1 represents full health, 0 represents death, and higher scores indicate a better outcome. The EQ VAS ranges from 0 to 100, where 0 represents the worst imaginable health state and 100 represents the best imaginable health state; higher scores indicate a better outcome.

    Measured: Up to 34 months

Timeline

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

  1. First posted21 Sep 2026
  2. Study startOct 2026 (estimated)
  3. Primary completionMar 2029 (estimated)
  4. Study completionDec 2029 (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
Masking
None (open label)
Enrolment
600 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07831863
Sponsor's protocol ID
7MW3711-CP301
Status last verified
Sep 2026
First submitted
4 Sep 2026
Last updated
21 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing 7MW3711 and Docetaxel in people with Lung Squamous Cell Carcinoma, run by Mabwell (Shanghai) Bioscience 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 12 inclusion and 19 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: opening soon, as of the sponsor's last update on 21 Sep 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 Shun Lu, Doctor (021-22200000 ext. 3121, shun_lu@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (time frame: Up to 34 months). 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 NCT07831863.

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 21 Sep 2026.

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