Volrustomig Priming Regimens Exploratory Phase II Platform Study​

Overview

Sponsor-declared trial summary

Key facts

Sponsor

AstraZeneca AB

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

3 Dec 2024 → ongoing

Decision date (initial)

2024-10-28

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

AstraZeneca AB

External identifiers

EU CT number

2023-509482-20-00

ClinicalTrials.gov

NCT06448754

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Others, Efficacy, Safety, Pharmacokinetic, Pharmacodynamic

To assess the safety and tolerability of volrustomig in combination with other anticancer drugs in participants with specified solid tumors.
To assess the efficacy of volrustomig in combination with other anticancer drugs in participants with specified solid tumors by assessment of ORR in participants.

Secondary objectives 3

1. To further assess the efficacy of volrustomig in combination with other anticancer drugs in participants with specified solid tumors by DCR at xx weeks, DoR, PFS, and OS.
2. To assess the serum concentrations of volrustomig and derived PK parameters.
3. To assess the incidence of ADAs against volrustomig or other anticancer agents in serum.

Conditions and MedDRA coding

Solid Tumors

Study design 1 period

Regulatory references

EMA paediatric investigation plan (PIP)

EMEA-003423-PIP01-23

Plan to share IPD

Yes

IPD plan description

Qualified researchers can request access to anonymised individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared. AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. When a request has been approved AstraZeneca will provide access to the anonymised individual patient-level data via secure research environment https://vivli.org/. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 8

1. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 with no deterioration
2. Life expectancy greater than or equal to (>=) 12 weeks
3. Adequate organ and bone marrow function.
4. Body weight greater than (>) 35 kilograms (kg) at screening and at randomization.
5. Histologically or cytologically documented NSQ NSCLC in substudy 1 and SQ or NSQ mNSCLC in substudy 2.
6. Absence of sensitizing epidermal growth factor receptor (EGFR) mutations.
7. Absence of documented tumor genomic alteration results from tests conducted as part of standard local practice in any other actionable driver oncogenes for which there are locally approved targeted 1L therapies.
8. At least one measurable lesion not previously irradiated that can be accurately measured at baseline as >= 10 millimeter (mm) in the longest diameter.

Exclusion criteria 6

1. Spinal cord compression.
2. History of primary active immunodeficiency.
3. Active or prior documented autoimmune or inflammatory disorders.
4. Mixed small-cell lung cancer and NSCLC histology or sarcomatoid variant.
5. Brain metastases unless asymptomatic, stable, and not requiring steroids for at least 14 days prior to start of study intervention. A minimum of 2 weeks must have elapsed between the end of radiation therapy and study enrollment.
6. Prior chemotherapy or any other systemic therapy for Stage IV NSCLC. Participants who have received prior platinum-containing adjuvant, neoadjuvant, or definitive chemoradiation for local disease are eligible, provided that progression has occurred greater(>) 12 months from end of last therapy.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. The safety and tolerability of volrustomig in combination with other anticancer drugs in participants with specified solid tumors will be assessed.
2. ORR is defined as the percentage of participants who have a confirmed complete response (CR) or confirmed partial response (PR), as per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST 1.1).

Secondary endpoints 8

1. DOR is defined as the time from the date of first documented response until the date of documented progression or death due to any cause (in the absence of progression).
2. PFS is defined as the time from randomization or first dose until radiological progression or death due to any cause (in the absence of progression).
3. OS is defined as the time from randomization or first dose until the date of death due to any cause.
4. The serum concentrations volrustomig alone and when used in combination with other anticancer agents in participants with pre-specified solid tumors will be assessed.
5. The trough concentrations volrustomig alone and when used in combination with other anticancer agents in participants with pre-specified solid tumors will be assessed.
6. The AUC concentrations of volrustomig alone and when used in combination with other anticancer agents in participants with pre-specified solid tumors will be assessed.
7. The incidence of ADAs against volrustomig or other anticancer agents in serum will be assessed.
8. DCR is defined as the percentage of participants who have a CR or PR or who have stable disease (SD) after the date of randomization or first dose.

Investigational products

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

Test 2

Auxiliary 5

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

AstraZeneca AB

Sponsor organisation

AstraZeneca AB

Address

-

City

Sodertalje

Postcode

151 85

Country

Sweden

Scientific contact point

Organisation

AstraZeneca AB

Contact name

AstraZeneca Clinical Study Information Center

Public contact point

Organisation

AstraZeneca AB

Contact name

AstraZeneca Clinical Study Information Center

Third parties 2

Locations

6 EU/EEA countries · 36 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 94 files

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

Application history

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