Study of efficacy and safety of JDQ443 in comparison with docetaxel in participants with locally advanced or metastatic KRAS G12C mutant non-small cell lung cancer.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Novartis Pharma AG

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

5 Sep 2022 → ongoing

Decision date (initial)

2024-09-10

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Novartis Pharma AG, OMS ID: ORG-100003908

External identifiers

EU CT number

2023-510082-10-00

EudraCT number

2021-002605-10

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety, Others, Pharmacodynamic, Pharmacokinetic, Therapy

To evaluate the progression free survival (PFS) of JDQ443 versus docetaxel

Secondary objectives 1

1. To characterize the safety profile of JDQ443 in study participants, including those who crossover from docetaxel

Conditions and MedDRA coding

Advanced non-small cell lung cancer harboring the KRAS G12C mutation

Regulatory references

Scientific advice from competent authorities

Food And Drug Administration

Plan to share IPD

Yes

IPD plan description

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. Participants are male and female, aged 18 or older
2. Histologically confirmed locally advanced (stage IIIB/IIIC not eligible for definitive chemoradiation or surgical resection with curative intent) or metastatic (stage IV) previously treated KRAS G12C-mutant NSCLC. Presence of a KRAS G12C mutation by central laboratory testing using tissue or blood samples, or assessed locally with GuardantHealth Guardant360® CDx liquid biopsy test or by a local laboratory utilizing the QIAGEN therascreen® KRAS RGQ PCR kit
3. Participants have received at least 1, but not more than 3, previous lines of treatment including one prior platinum-based chemotherapy and one prior immune checkpoint inhibitor therapy either in combination or in sequence
4. Participants with ECOG performance status from 0 to 2

Exclusion criteria 3

1. Participants who have previously received docetaxel (except if received in neoadjuvant or adjuvant setting with no progression within 12 months after the of end of treatment), or any other KRAS G12C inhibitor
2. Participants whose tumors harbor an epidermal growth factor receptor (EGFR)-sensitizing mutation and/or anaplastic lymphoma kinase (ALK) rearrangement by local testing. Participants with other known druggable alterations will be excluded, if required by local guidelines
3. History of severe hypersensitivity reaction to taxanes or any excipients of these study treatments

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Progression free survival (PFS) per RECIST 1.1 as assessed by the investigator

Secondary endpoints 1

1. Type, frequency and severity of adverse events, changes in laboratory values, vital signs, ECGs

Investigational products

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

Test 1

Comparator 1

Auxiliary 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Novartis Pharma AG

Sponsor organisation

Novartis Pharma AG

Address

Lichtstrasse 35

City

Basel

Postcode

4056

Country

Switzerland

Scientific contact point

Organisation

Novartis Pharma AG

Contact name

Novartis Pharma Arzneimittel GmbH

Public contact point

Organisation

Novartis Pharma AG

Contact name

Novartis Pharma Arzneimittel GmbH

Third parties 16

Locations

9 EU/EEA countries · 16 investigational sites

By country

Investigational sites

Country notifications

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

Oversight and notifications

Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77

Temporary halts 8 · Art. 38 CTR

Results and documents

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

Documents 95 files

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

Application history

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