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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

ConditionAdvanced or Metastatic Squamous Non-Small Cell Lung Cancer
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorShanghai Henlius Biotech

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • HLX43

    Drug

    Anti-PD-L1 ADC

  • HLX43+HLX07

    Drug

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

  • Docetaxel

    Drug

    Active Comparator

Treatment groups

706 Participants
are divided into 3 treatment groups
Group A: HLX43Experimental treatment 1 intervention
Group B: HLX43 + HLX07Experimental treatment 1 intervention
Group C: docetaxelActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Overall survival (OS)

Time frame
approximately up to 24 months
2

PFS

assessed by the Blinded Independent Central Review \[BICR\]

Time frame
approximately up to 24 months

Secondary outcomes

1

PFS

assessed by the investigator

Time frame
approximately up to 24 months
2

ORR

assessed by the BICR and the investigator

Time frame
approximately up to 24 months
3

DOR

assessed by the BICR and the investigator

Time frame
approximately up to 24 months
4

DCR

assessed by the BICR and the investigator

Time frame
approximately up to 24 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shanghai Henlius Biotech

Lead sponsor

Source ClinicalTrials.gov
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