Study to Compare AMG 510 "Proposed INN Sotorasib" With Docetaxel in Non Small Cell Lung Cancer (NSCLC) (CodeBreak 200)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Amgen Inc.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

25 May 2020 → ongoing

Decision date (initial)

2024-02-09

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Amgen Inc.

External identifiers

EU CT number

2023-508214-42-00

EudraCT number

2019-003582-18

WHO UTN

U1111-1299-8224

ClinicalTrials.gov

NCT04303780

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacokinetic, Safety, Efficacy

To compare the efficacy of AMG 510 versus docetaxel as assessed by progression-free survival (PFS) in previously treated subjects with KRAS p.G12C mutated non-small cell lung cancer (NSCLC)

Secondary objectives 6

1. To compare the efficacy of AMG 510 versus docetaxel as assessed by:  Overall Survival (OS)  Objective response rate (ORR)
2. To compare patient-reported outcomes (PRO) as assessed by: European Organization for Research and Treatment of Cancer Quality-of-life Questionnaire Core 13 (EORTC QLQ-LC13) and European Organization for Research and Treatment of Cancer Quality-of-life Questionnaire Core 30 (EORTC QLQ-C30)
3. To compare efficacy of AMG 510 versus docetaxel as assessed by: duration of response (DOR), time to response (TTR), and disease control rate (DCR)
4. To compare the safety and tolerability of AMG 510 versus docetaxel
5. To compare the effect of treatment with AMG 510 on other treatment and disease related symptoms, and health related quality of life relative to docetaxel
6. To characterize the pharmacokinetics (PK) of AMG 510 and its major metabolites

Conditions and MedDRA coding

Previously treated locally advanced and unresectable or metastatic non-small cell lung cancer (NSCLC) with KRAS p.G12C mutation

Study design 1 period

Regulatory references

Scientific advice from competent authorities

European Medicines Agency

Plan to share IPD

Yes

IPD plan description

De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request. Further information on IPD Sharing Access Criteria, IPD sharing time frame and sharing supporting information types is available at ClinicalTrials.gov (https://www.clinicaltrials.gov/study/NCT04303780?id=NCT04303780&rank=1) and at Amgen Clinical Trials portal at (http://www.amgen.com/datasharing).

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

1. Men or women greater than or equal to 18 years old.
2. ECOG ≤ 1
3. Pathologically documented, previously treated, locally-advanced and unresectable or metastatic NSCLC with KRAS p.G12C mutation confirmed through central testing or have documentation of KRAS p.G12C mutation through Amgen Study 20190294 prior to enrollment

Exclusion criteria 3

1. Active brain metastases
2. Myocardial infarction within 6 months of study day 1
3. Gastrointestinal (GI) tract disease causing the inability to take oral medication

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. PFS - defined as time from randomization until disease progression or death from any cause, whichever occurs first for all subjects. Progression will be based on blinded independent central review (BICR) of disease response per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).

Secondary endpoints 4

1. Overall survival - defined as time from randomization until death from any cause.
2. Objective response (complete response [CR] + partial response [PR]), assessed per RECIST v1.1. Response will be assessed by BICR. Complete response and PR require confirmatory repeat radiologic assessment at no less than 4 weeks after the original response. The normal subsequent assessment is acceptable to confirm response.
3. Change from baseline (cycle 1 day 1) over time to week 12 in disease related symptoms of: - Dyspnea as measured by a 4-item dyspnea domain from QLQ-C30 and QLQ-LC13 - Cough as measured by QLQ-LC13 - Chest Pain as measured by QLQ-LC13
4. Change from baseline over time to week 12 in: - Physical functioning as measured by QLQ-C30 - Global health status as measured by QLQ-C30

Investigational products

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

Test 1

Comparator 1

Auxiliary 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Amgen Inc.

Sponsor organisation

Amgen Inc.

Address

1 Amgen Center Drive

City

Thousand Oaks

Postcode

91320-1799

Country

United States

Scientific contact point

Organisation

Amgen Inc.

Contact name

Medical Information

Public contact point

Organisation

Amgen Inc.

Contact name

Medical Information

Third parties 12

Locations

8 EU/EEA countries · 30 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 84 files

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

Application history

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