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Advanced or Metastatic Squamous Non-Small Cell Lung CancerPhase 2/3NCT07459751

A Global Phase II/III Clinical Study to Evaluate the Efficacy and Safety of HLX43 Monotherapy or HLX43 in Combination With HLX07 Versus Docetaxel in Advanced or Metastatic Squamous Non-Small Cell Lung Cancer

A Phase 2/3 study testing HLX43, HLX43+HLX07 and Docetaxel in people with Advanced or Metastatic Squamous Non-Small Cell Lung Cancer, run by Shanghai Henlius Biotech 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
Search all trials

Trial summary

This is a randomized, open-label, multi-center, global phase II/III clinical study to evaluate the efficacy and safety of HLX43 monotherapy or HLX43 in combination with HLX07 vs. docetaxel in the treatment of advanced squamous NSCLC after failure of first-line treatment. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
HLX43, HLX43+HLX07 and Docetaxel
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
706 participants
Where
1 siteChina
Study dates
27 May 2026to 15 Jan 2030
Phase
Phase 2/3
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

  • Have a full understanding of the study content, process, and possible adverse reactions before the study, and sign the informed consent form (ICF); voluntarily participate in the study; be able to complete the study as per protocol requirements;
  • Aged ≥ 18 years at the time of signing the ICF, male or female;
  • Histologically or cytologically confirmed squamous NSCLC, locally advanced (stage IIIB/IIIC) or metastatic (stage IV) NSCLC not suitable for radical treatment (complete surgical resection, concurrent/sequential radio-chemotherapy) according to the Union for International Cancer Control and the American Joint Committee on Cancer (AJCC) TNM staging system (8th edition);
  • Subjects must have progressed after platinum-based chemotherapy in combination with anti-PD-1/anti-PD-L1 therapy as the only prior first-line treatment or progressed after platinum-based chemotherapy followed by anti-PD-1/anti-PD-L1 therapy (in any order) as the only prior second-line treatment.
  • Note: Definition of prior treatment failure with platinum-based chemotherapy:
  • Progressive disease following platinum-based chemotherapy in the recurrent or metastatic setting;
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  • Progressive disease or recurrence during platinum-based chemotherapy, or within 6 months after the end of platinum-based chemotherapy in the neoadjuvant chemotherapy, concurrent radio-chemotherapy, or adjuvant chemotherapy setting;
  • Intolerance to platinum-based chemotherapy; 5. At least one measurable lesion as per RECIST v1.1 within 4 weeks prior to randomization; Note: Measurable target lesions should not be selected from previous radiotherapy sites or brain lesions. A measurable lesion within the field of local radiotherapy can be selected as the target lesion only when it is the only optional target lesion and the imaging evidence before and after progression should be available.
  • 6. Subjects who agree to provide archived tumor tissue specimens that meet the testing requirements (either from the most recent surgery or biopsy, preferably within 2 years) or agree to undergo a biopsy to collect tumor tissues for PD-L1 and EGFR expression testing; Note: Formalin-fixed paraffin-embedded (FFPE) tumor samples (paraffin blocks or unstained sections, which must meet the quality control criteria for testing) collected from non-radiotherapy sites during the most recent surgery or biopsy at or after the diagnosis of malignant tumor and pathological reports of such specimens shall also be provided.
  • 7. The following conditions must be met in terms of the time of the first administration of the investigational product: at least 3 weeks (or 5 half-lives of the drug, whichever is shorter) from the previous major surgery, medical device treatment, locoregional radiotherapy (except for palliative radiotherapy for bone lesions), cytotoxic chemotherapy, or immunotherapy; at least 1 week from the administration of the traditional Chinese medicine for anti-cancer indications or minor surgery; and recovery of treatment-induced AEs to Grade ≤ 1 (CTCAE v5.0, except for Grade 2 peripheral neurotoxicity and alopecia); 8. ECOG PS score of 0-1 within 1 week prior to randomization; 9. Life expectancy > 3 months; 10. Adequate organ functions as confirmed by laboratory tests within 1 week prior to randomization (no blood transfusions or treatment with granulocyte colony-stimulating factor within 14 days prior to the first dose); 11. Male and female subjects with child-bearing potential must agree to use at least one highly effective contraception method during the study and within at least 6 months after the last dose of the investigational product; female subjects of childbearing age must be negative for pregnancy test within 7 days prior to enrollment.

Who cannot join

  • Histologically or cytologically confirmed tumor containing components of small cell lung cancer, neuroendocrine carcinoma, or sarcomatoid carcinoma;
  • Prior treatment with any medication targeting topoisomerase I, including chemotherapy or ADCs;
  • Prior treatment with docetaxel;
  • Radical radiation therapy within 3 months prior to the first dose;
  • History of any second malignancy within 2 years prior to randomization, except for early-stage malignancies (carcinoma in situ or stage I tumors) that have received radical treatment, such as non-melanoma skin cancer, cervical carcinoma in situ, localized prostate cancer, ductal carcinoma in situ of the breast, and papillary thyroid carcinoma;
  • History of ≥ Grade 3 irAEs in immunotherapy;
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  • Presence of uncontrollable pleural effusion, pericardial effusion, or ascites requiring repeated drainage;
  • Presence of spinal cord compression or clinically active metastases to central nervous system (referring to untreated or symptomatic metastases, or metastases requiring corticosteroids or anticonvulsants to control associated symptoms), carcinomatous meningitis. Subjects who have previously received treatment for brain metastases (such as whole brain radiotherapy or stereotactic brain radiotherapy) may be eligible, provided that they are clinically stable for at least 4 weeks with no imaging evidence of brain metastasis progression;
  • Subjects with current and prior history of clinically significant pulmonary impairment due to pulmonary comorbidities, including but not limited to: any underlying lung disease (e.g., pulmonary embolism, severe asthma, severe chronic obstructive pulmonary disease, restrictive lung disease, interstitial pneumonia, pneumoconiosis, and drug-related pneumonitis within 3 months prior to the first dose), any autoimmune, connective tissue, or inflammatory disease that may involve the lungs (i.e., rheumatoid arthritis, Sjogren's syndrome, and sarcoidosis), prior pneumonectomy that may interfere with the detection and management of suspected drug-related pulmonary toxicity, or history of radiation pneumonitis within 6 months;
  • Patients with any poorly-controlled cardiovascular and cerebrovascular clinical symptoms or diseases, including but not limited to:
  • NYHA Class II or greater heart failure or left ventricular ejection fraction (LVEF) < 50%; (2) unstable angina pectoris; (3) myocardial infarction or cerebrovascular accident within 6 months (except lacunar infarction, slight cerebral ischemia, or transient ischemic attack); (4) poorly controlled arrhythmia (including QTc interval ≥ 470 ms) (QTc interval is calculated by Fridericia's formula); (5) poorly-controlled hypertension (systolic blood pressure > 150 mmHg and/or diastolic blood pressure > 100 mmHg after active treatment); 11. Patients with active systemic infectious diseases requiring intravenous antibiotics within 2 weeks prior to randomization; 12. Patients who have used moderate or potent CYP2D6 or CYP3A inhibitors or inducers within 2 weeks prior to randomization; 13. Patients who have received systemic corticosteroids (prednisone > 10 mg/d or equivalent dose of similar drug) or other immunosuppressants within 2 weeks prior to randomization; Except: patients treated with topical, ocular, intra-articular, intranasal, and inhaled corticosteroids; short-term prophylactic use of corticosteroids for contrast agents, etc.; 14. Patients with known active or suspected autoimmune diseases. Patients with autoimmune-related hypothyroidism and receiving thyroid hormone replacement therapy and those with type 1 diabetes mellitus controlled with insulin therapy are eligible to be enrolled; 15. Patients who have received live vaccine or live attenuated vaccine within 4 weeks prior to randomization; 16. Patients who are known to have anaphylaxis to macromolecular protein preparations/monoclonal antibodies or are allergic to any component in the formulation of the investigational product; 17. Patients with active tuberculosis; 18. Patients with a history of immunodeficiency, including human immunodeficiency virus (HIV)-positive or other acquired or congenital immunodeficiencies, or history of organ transplantation; 19. Patients with active HBV or HCV infection or HBV/HCV co-infection; Note: Patients who test positive for HBsAg or HBcAb during screening must further undergo HBV-DNA testing. If the test result suggests < 500 IU/mL, < 2500 copies/mL, or < ULN, the patient can be enrolled. Patients with HBV-DNA detected must agree to receive treatment with anti-HBV nucleos(t)ide analogues during the study.
  • Patients who test positive for HCV antibody must further undergo HCV-RNA testing. If the test result suggests < ULN, the patient can be enrolled.
  • Patients with HBV/HCV co-infection (positive for HBsAg or HBcAb and positive for HCV antibody) must be excluded.
  • 20. Pregnant or lactating women; 21. Patients who are not suitable for participating in this clinical study due to any clinical or laboratory abnormalities or other reasons as assessed by the investigator.

Trial locations and contacts

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

Jie Wang contact

8610-87788495

zlhuxi@163.com

China1 site, 1 recruiting

  • Cancer Hospital, Chinese Academy of Medical Sciences

    Beijing, Beijing Municipality, 100021

    Jie Wang, 8610-87788495, zlhuxi@163.com

    Recruiting

Other trials in China

About this study

Official title: A Randomized, Open-Label, Multi-center, Global Phase II/III Clinical Study to Evaluate the Efficacy and Safety of HLX43 (Anti-PD-L1 ADC) Monotherapy or HLX43 in Combination With HLX07 (Recombinant Anti-EGFR Humanized Monoclonal Antibody Injection) Versus Docetaxel in Previously Treated Advanced or Metastatic Squamous Non-Small Cell Lung Cancer (NSCLC)

This is a randomized, open-label, multi-center, global phase II/III clinical study to evaluate the efficacy and safety of HLX43 monotherapy or HLX43 in combination with HLX07 vs. docetaxel in the treatment of advanced squamous NSCLC after failure of first-line treatment.

Being tested
HLX43, HLX43+HLX07, Docetaxel

What participants receive

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

  • HLX43Drug

    Anti-PD-L1 ADC

  • HLX43+HLX07Drug

    Anti-PD-L1 ADC + Recombinant Anti-EGFR Humanized Monoclonal Antibody Injection

  • DocetaxelDrug

    Active Comparator

Study groups in NCT07459751
Study groupRoleWhat they receive
HLX43ExperimentalHLX43 intravenously on Day 1 of each 3-week cycle
Receives: Drug: HLX43
HLX43 + HLX07ExperimentalHLX43 and HLX07 intravenously on Day 1 of each 3-week cycle;
Receives: Drug: HLX43+HLX07
docetaxelActive comparatorDocetaxel intravenously on Day 1 of each 3-week cycle
Receives: Drug: Docetaxel

What is being measured

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

  1. Overall survival (OS)

    Measured: approximately up to 24 months

  2. PFS

    assessed by the Blinded Independent Central Review [BICR]

    Measured: approximately up to 24 months

Secondary outcomes (5)

  1. PFS

    assessed by the investigator

    Measured: approximately up to 24 months

  2. ORR

    assessed by the BICR and the investigator

    Measured: approximately up to 24 months

  3. DOR

    assessed by the BICR and the investigator

    Measured: approximately up to 24 months

  4. DCR

    assessed by the BICR and the investigator

    Measured: approximately up to 24 months

  5. Incidence and severity of adverse events (AEs)

    severity determined according to National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] Version [v] 5.0

    Measured: time from the date of the first dose of study drug until the date of death from any cause, assessed up to 24 months

Timeline

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

  1. First posted10 Mar 2026
  2. Study start27 May 2026
  3. Primary completion15 Jan 2030 (estimated)
  4. Study completion15 Jan 2030 (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 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
706 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07459751
Sponsor's protocol ID
HLX43-NSCLC302
Status last verified
May 2026
First submitted
5 Mar 2026
Last updated
1 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing HLX43, HLX43+HLX07 and Docetaxel in people with Advanced or Metastatic Squamous Non-Small Cell Lung Cancer, run by Shanghai Henlius Biotech 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 10 inclusion and 14 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 1 Jun 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 combined 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.

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 Jie Wang (8610-87788495, zlhuxi@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall survival (OS) (time frame: approximately up to 24 months). 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 NCT07459751.

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 1 Jun 2026.

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