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A Study to Compare the Efficacy, Safety, Immunogenicity, and Pharmacokinetic Profile of HLX17 Vs. Keytruda® in the First-Line Treatment of Advanced Non-squamous Non-small Cell Lung Cancer

ConditionNon-Squamous Non-Small Cell Lung Cancer
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorShanghai Henlius Biotech

About this trial

This is a multicentre, randomized, double-blind, parallel-controlled integrated phase I/III clinical study to evaluate the similarity in efficacy, safety, PK profile, and immunogenicity of HLX17 vs. Keytruda®( US- and EU-sourced) in the first-line treatment of advanced non-squamous non-small cell lung cancer.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Histologically or cytologically confirmed diagnosis of stage IV inoperable to surgery or radiotherapy (AJCC 8th edition) non-squamous NSCLC.

Without any tumor activating EGFR mutation or ALK or ROS1 gene rearrangement.

Have not received prior systemic treatment for their advanced/metastatic NSCLC.

At least one measurable lesion as assessed by IRRC based on RECIST v1.1.

Disqualifiers

Subjects with NSCLC of other histopathological types, such as mixed adenosquamous carcinoma, and subjects with small cell lung cancer or neuroendocrine carcinoma.

Subjects with other active malignancies within 5 years or at the same time prior to screening.

Active central nervous system metastases.

Known interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonitis, and severe lung function abnormalities that may impede the investigators' diagnosis and management of drug-related pulmonary toxicity.

Trial design

Design model

Parallel

Treatments tested in this trial

  • HLX17

    Drug

    HLX17 will be administered as IV infusion at a dose of 200mg on Day 1 of each 21-day cycle in combination with Carboplatin and Pemetrexed until loss of clinical benefit or up to 1 year.

  • US-sourced Keytruda®

    Drug

    US-sourced Keytruda® will be administered as IV infusion at a dose of 200mg on Day 1 of each 21-day cycle in combination with Carboplatin and Pemetrexed. After 24 weeks, all subjects in the US-Keytruda® group will receive HLX17 in combination with Pemetrexed until loss of clinical benefit or up to 1 year.

  • EU-sourced Keytruda®

    Drug

    EU-sourced Keytruda® will be administered as IV infusion at a dose of 200mg on Day 1 of each 21-day cycle in combination with Carboplatin and Pemetrexed until loss of clinical benefit or up to 1 year.

Treatment groups

772 Participants
are divided into 3 treatment groups
Group A: HLX17 groupExperimental treatment 1 intervention
Group B: US-sourced Keytruda® groupActive comparator 1 intervention
Group C: EU-sourced Keytruda® groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Area under the serum concentration-time curve from time 0 to 21 days (AUC0-21d)

Time frame
Up to Day 21
2

Area under the serum concentration-time curve within a dosing interval at steady state (AUCss)

Time frame
Up to 1 year
3

Best Objective Response Rate (BORR) assessed by Independent Radiology Review Committee (IRRC) based on RECIST v1.1

Time frame
up to week 24

Secondary outcomes

1

Maximum serum drug concentration (Cmax) after the first dose

Time frame
Up to Day 21
2

Trough serum drug concentration (Ctrough) after the first dose

Time frame
Up to Day 21
3

Area under the serum concentration-time curve from time 0 to infinity (AUC0-inf) after the first dose

Time frame
Up to Day 21
4

Area under the serum concentration-time curve extrapolated from time t to infinity as a percentage of total AUC (%AUCex) after the first dose

Time frame
Up to Day 21

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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

Shanghai Henlius Biotech

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: