A Study of Tislelizumab in Combination With Investigational Agents in Participants With Non-Small Cell Lung Cancer.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

BeOne Medicines AG

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

15 Sep 2023 → ongoing

Decision date (initial)

2023-08-23

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

BeiGene Ltd.

External identifiers

EU CT number

2022-502738-18-00

ClinicalTrials.gov

NCT05635708

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety

To assess the antitumor activity of tislelizumab plus investigational agent(s) with or without chemotherapy.

Secondary objectives 2

1. To further assess the antitumor activity of tislelizumab plus investigational agent(s) with or without chemotherapy.
2. To assess the safety and tolerability of tislelizumab plus investigational agent(s) with or without chemotherapy.

Conditions and MedDRA coding

Metastatic Non-small Cell Lung Cancer

Regulatory references

EMA paediatric investigation plan (PIP)

EMEA-002480-PIP01-18

Plan to share IPD

Yes

IPD plan description

BeiGene shares data on completed studies responsibly and provides qualified scientific and medical researchers access to data and supporting documentation for clinical trials in dossiers for medicines and indications after submission and approval in the United States, China, and Europe. Clinical trials supporting subsequent local approvals, new indications, or combination products are eligible for sharing once corresponding regulatory approvals are achieved. BeiGene shares data only when permitted by applicable data privacy and security laws and regulations, and shared when it is feasible to do so without compromising the privacy of study participants. Qualified researchers with appropriate competencies who are engaged in novel scientific research may submit a request for participant-level data along with a research proposal for BeiGene review. Research teams must include a biostatistician and sign a Data Sharing Agreement prior to receiving access to clinical trial data.

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. Histologically or cytologically confirmed NSCLC (nonsquamous or squamous) that is locally advanced or recurrent and not eligible for curative surgery and/or definitive chemoradiotherapy, or metastatic NSCLC.
2. No prior systemic treatment given as primary therapy for metastatic NSCLC. Prior adjuvant/neoadjuvant chemotherapy or definitive chemoradiation/adjuvant radiotherapy for locally advanced disease is allowed provided the last dose of chemotherapy and/or radiotherapy occurred at least 6 months before randomization/enrollment.
3. Evaluable tumor PD-L1 expression as determined by a local laboratory or by central laboratory on archival tumor tissue or fresh biopsy. Patients with unknown PD-L1 expression will not be eligible for this study.
4. At least 1 measurable lesion as defined per RECIST v1.1
5. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
6. NOTE: Other protocol and sub-study protocol defined criteria may apply

Exclusion criteria 6

1. Has mixed small cell lung cancer.
2. Patients with known EGFR mutations or actionable mutations with available targeted therapies.
3. Prior therapy with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-TIGIT, anti-LAG-3 or any other antibody or drug targeting T-cell costimulation or immune checkpoint pathways. Note: Patients who received prior neoadjuvant, adjuvant or immuno-oncology therapies targeting PD-1 or PD-L1 in consolidation are eligible, if there has been a treatment-free interval of ≥ 6 months from last dose of immuno-oncology therapy prior to radiologic recurrence of disease.
4. Has received any Chinese herbal medicine or Chinese patent medicines used to control cancer ≤ 14 days before randomization/enrollment.
5. Active leptomeningeal disease or uncontrolled, untreated brain metastasis, or active autoimmune diseases.
6. NOTE: Other protocol and sub-study protocol defined criteria may apply

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Confirmed overall response rate (ORR) as assessed by the investigators per Response Evaluation Criteria in Solid Tumors (RECIST) Version (v)1.1

Secondary endpoints 4

1. Progression-free survival (PFS), duration of response (DOR), clinical benefit rate (CBR), and disease control rate (DCR) as assessed by the investigator per RECIST v1.1.
2. The incidence and severity of adverse events according to National Cancer Institute Common Terminology Criteria for Adverse Events NCI-CTCAE v5.0 in reference arms and experimental arms.
3. Plasma or serum concentrations of tislelizumab and investigational agents at specified timepoints.
4. Immunogenic responses to tislelizumab and investigational protein therapeutics, evaluated through the detection of antidrug antibodies (ADA).

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 4

Auxiliary 5

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

BeOne Medicines AG

Sponsor organisation

BeOne Medicines AG

Address

Aeschengraben 27

City

Basel

Postcode

4051

Country

Switzerland

Scientific contact point

Organisation

BeOne Medicines AG

Contact name

BeOne Medical Officer

Public contact point

Organisation

BeOne Medicines AG

Contact name

BeOne Medical Officer

Third parties 9

Locations

4 EU/EEA countries · 9 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 75 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

15 submissions — initial application plus substantial / non-substantial modifications