A Phase 3 Study to Compare AMG 510 With Docetaxel in NSCLC Subjects With KRAS p.G12C Mutation (CodeBreak 200)

Phase 1

• Conditions: Previously treated locally advanced and unresectable or metastatic non small cell lung cancer (NSCLC) with KRAS p.G12C mutation; MedDRA version: 21.1Level: PTClassification code 10061873Term: Non-small cell lung cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2019-003582-18-IT
• Lead Sponsor: AMGEN INC.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-06-17
• Last Update Posted: 30 August 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 650

Inclusion Criteria

• Subject or subject's legally acceptable representative has provided informed consent prior to initiation of any study specific activities/procedures.
• Age > = 18 years of age
• Have documentation of KRAS p.G12C mutation confirmed by central testing through the current protocol or Amgen Study 20190294 prior to enrollment.
• Subjects will have received and progressed or experienced disease recurrence on or after at least 1 prior systemic therapy for locally advanced and unresectable or metastatic disease. Prior treatment must include a platinum-based doublet chemotherapy and checkpoint inhibitor for advanced or metastatic disease, either given as one line of therapy or as individual lines of therapy unless the subject has a medical contraindication to one of the required therapies. If the subject has a medical contraindication to a required therapy, the subject may be enrolled only after the investigator discusses and obtains approval from the Amgen medical monitor.
a) Adjuvant therapy will count as a line of therapy if the subject progressed on or within 6 months of adjuvant therapy administration.
b) In locally advanced and unresectable NSCLC, disease progression on or within 6 months of end of prior curatively intended multimodal therapy will count as a line of therapy. If chemoradiation is followed by planned systemic therapy without documented progression between chemoradiation and systemic therapy, the entire treatment course counts as one line of therapy.

*Please, refers to the protocol for the full list
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 500
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 150

Exclusion Criteria

• Subjects have received prior docetaxel in unresectable or metastatic setting.
• Mixed small-cell lung cancer and NSCLC histology
• Previously identified driver mutation (according to local standard of care or guidelines) other than KRAS p.G12C for which an approved therapy is available (including EGFR, ALK, etc).
• Active brain metastases. Subjects who have had brain metastases resected or have received whole brain radiation therapy ending at least 4 weeks (or stereotactic radiosurgery ending at least 2 weeks) prior to study day 1 are eligible if they meet all of the following criteria:
a) residual neurological symptoms grade < = 2;
b) on stable doses of dexamethasone or equivalent for at least 2 weeks, if applicable; and
c) follow-up MRI performed within 30 days prior to enrollment shows no progression or new lesions appearing.
• Leptomeningeal disease.
• Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures at a frequency greater than monthly. Subjects with PleurX catheters in place may be considered for the study with Medical Monitor approval.

*Please, refers to protocol for the full list.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified