A Phase 3 Multicenter, Randomized, Open Label, Active-controlled, Study of AMG 510 Versus Docetaxel for the Treatment of Previously Treated Locally Advanced and Unresectable or Metastatic NSCLC Subjects With Mutated KRAS p.G12C
- Conditions
- Lung cancerLung tumor10038666
- Registration Number
- NL-OMON56228
- Lead Sponsor
- Amgen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 56
Histologically or pathologically documented, locally-advanced and unresectable
or metastatic NSCLC.
104. Have documentation of KRAS p.G12C mutation confirmed by central testing
through the current protocol or have documentation of KRAS p.G12C mutation
through Amgen Study 20190294 prior to enrollment.
105. 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.
c) Maintenance therapy following platinum doublet-based chemotherapy is not
considered as a separate line of therapy.
106. Subjects must have archived tumor tissue samples collected within 5 years
or be willing to undergo pre-treatment tumor biopsy for tissue prior to
enrollment.
107. Measurable disease per RECIST v1.1 criteria. Lesions previously radiated
are not considered measurable unless they have progressed after radiation.
108. ECOG Performance Status of =< 1
109. Adequate hematologic laboratory assessments, defined as the following
within 10 days prior to start of study therapy:
110. Life expectancy of > 3 months, in the opinion of the investigator
Please refer to section 5.1 of the protocol.
Subjects have received prior docetaxel in unresectable or metastatic setting
(including subjects who received prior docetaxel in first line for metastatic
disease, but not including subjects who received prior docetaxel neoadjuvantly
or adjuvantly and did not progress within 6 months of end of therapy).
202. Mixed small-cell lung cancer or mixed NSCLC histology
203. 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).
204. 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.
Active brain metastases are defined as: Untreated brain lesions (new or
progressing) and/or symptomatic brain lesions (symptoms as determined by the
investigator), present at the time of study entry.
205. Leptomeningeal disease.
206. 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.
-Other Medical Conditions, Prior/Concomitant Therapy, Prior/Concurrent Clinical
Study Experience and Other Exclusions are listed in protocol page 52-55
Please refer to section 5.2 of the protocol.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Progression will be based on blinded independent central review (BICR) of<br /><br>disease response per RECIST version 1.1.</p><br>
- Secondary Outcome Measures
Name Time Method <p>• Overall survival - defined as time from randomization until death from any<br /><br>cause.<br /><br>• ORR Response will be assessed by BICR.<br /><br><br /><br>• Dyspnea as measured by QLQ-LC13<br /><br>• Cough as measured by QLQ LC13<br /><br>• Chest Pain as measured by QLQ-LC13<br /><br><br /><br>Refer to section 3 of the protocol.</p><br>