Evidence Level:Sensitive: C2 – Inclusion Criteria
New
Title:
Sotorasib in patients with non-small cell lung cancer with genetic changes with comorbidities
Excerpt:...Documented KRASG12C mutation, based on tissue analysis on either archived tissue or new biopsy before inclusion, and verified locally by a validated method. ...
Evidence Level:Sensitive: C2 – Inclusion Criteria
New
Title:
AMG 510 Expanded Access Protocol in Selected European Countries Protocollo di accesso allargato su AMG 510 in Paesi europei selezionati
Excerpt:...- Subject has provided informed consent prior to initiation of any study specific activities/procedures.- Age >= 18 years.- Pathologically documented, locally-advanced, and unresectable or metastatic non-small cell lung cancer.- Have documentation of KRAS p.G12C mutation per local testing guidelines or a screening for another Amgen sotorasib study.- Subject has exhausted other standard of care options for locally advanced and unresectable or metastatic disease including platinum-based combination chemotherapy, PD-1/PD-L1 immunotherapy, and docetaxel (unless contraindicated).- Eastern Cooperative Oncology Group (ECOG) performance status = 18 anni- Carcinoma polmonare non a piccole cellule patologicamente documentato, localmente avanzato e non resecabile o metastatico- Mutazione per KRAS p.G12C documentata secondo le linee guida dei test locali o al momento dello screening per altri studi Amgen con sotorasib- I soggetti non hanno più opzioni terapeutiche tra gli standard of care per malattia localmente avanzata e non resecabile o metastatica inclusa chemioterapia di combinazione a base di platino, immunoterapia PD-1/PD-L1 e docetaxel (a meno che non sia controindicato)- Performance status dell'Eastern Cooperative Oncology Group (ECOG) otocollo per la lista completa`- Subject has provided informed consent prior to initiation of any study specific activities/procedures.- Age ≥ 18 years.- Pathologically documented, locally-advanced, and unresectable or metastatic non-small cell lung cancer.- Have documentation of KRAS p.G12C mutation per local testing guidelines or a screening for another Amgen sotorasib study.- Subject has exhausted other standard of care options for locally advanced and unresectable or metastatic disease including platinum-based combination chemotherapy, PD-1/PD-L1 immunotherapy, and docetaxel (unless contraindicated).- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 - Adequate hematologic and end-organ function, defined as the following: - Absolute neutrophil count (ANC) > 1000 cells/μl (without granulocyte colony-stimulating factor support within 2 weeks of laboratory test used to determine eligibility) - Hemoglobin ≥ 9.0 g/dL - Platelet count ≥ 75 000/μL - AST and ALT < 2.5 x the upper limit of normal (ULN) (if liver metastases are present, ≤ 5 x ULN) - Total bilirubin < 1.5 x ULN (subjects with known Gilbert’s disease with serum bilirubin < 3 x ULN may be enrolled if direct bilirubin is < 1 x ULN and approved by Amgen Medical Monitor) - International normalized ratio (INR) or activated partial thromboplastin time (aPTT) < 1.5 x ULN - Serum creatinine ≤ 1.5 x ULN OR estimated glomerular filtration rate (eGFR) ≥ 45 mL/min/1.73 m2. ...
More C2 evidence
Evidence Level:Sensitive: C2 – Inclusion Criteria
New
Title:
Testing the Use of Targeted Treatment (AMG 510) for KRAS G12C Mutated Advanced Non-squamous Non-small Cell Lung Cancer (A Lung-MAP Treatment Trial)
Excerpt:...Biomarker eligibility for S1900E is based on the identification of a KRAS^G12C mutation...
Evidence Level:Sensitive: C2 – Inclusion Criteria
New
Title:
Sotorasib Activity in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation (CodeBreak 101)
Excerpt:...- Pathologically documented, locally-advanced or metastatic malignancy with, KRAS p.G12C mutation identified through molecular testing performed according to in-country requirements....
Evidence Level:Sensitive: C2 – Inclusion Criteria
New
Title:
A Phase 1/2, Study Evaluating the Safety, Tolerability, PK, and Efficacy of Sotorasib (AMG 510) in Subjects With Solid Tumors With a Specific KRAS Mutation (CodeBreaK 100)
Excerpt:...- Pathologically documented, locally-advanced or metastatic malignancy with, KRAS p.G12C mutation identified through molecular testing....
Evidence Level:Sensitive: C2 – Inclusion Criteria
New
Title:
A Phase II Study of Neoadjuvant Sotorasib in Combination With Cisplatin or Carboplatin and Pemetrexed for Surgically Resectable Stage IIA-IIIB Non-Squamous Non-Small Cell Lung Cancer With a KRAS p.G12C Mutation
Excerpt:...Identification of a KRAS p.G12C mutation in tumor tissue or plasma by an approved diagnostic device for detection of KRAS p.G12C in NSCLC or through any nucleic acid-based diagnostic testing method [including droplet-digital PCR, real-time PCR based methods such as the Idylla KRAS Mutation Assay (Biocartis), tissue and circulating tumor DNA -based next generation sequencing, Sanger-sequencing etc] performed in a Clinical Laboratory Improvement Amendments (CLIA)-certified or equivalently accredited laboratory....
Evidence Level:Sensitive: C2 – Inclusion Criteria
New
Title:
Study to Compare AMG 510 "Proposed INN Sotorasib" With Docetaxel in Non Small Cell Lung Cancer (NSCLC) (CodeBreak 200).
Excerpt:...- 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...
Evidence Level:Sensitive: C2 – Inclusion Criteria
New
Title:
SHP2 Inhibitor BBP-398 in Combination With Sotorasib in Patients With Advanced Solid Tumors and a KRAS-G12C Mutation
Excerpt:...- Patients must have histologically documented, locally advanced and unresectable, or metastatic solid tumor with documentation of a KRAS-G12C mutation within 2 years prior to screening....
Evidence Level:Sensitive: C2 – Inclusion Criteria
New
Title:
Sotorasib in Advanced KRASG12C-mutated Non-small Cell Lung Cancer Patients With Comorbidities
Excerpt:...- Documented KRASG12C mutation, based on tissue analysis on either archived tissue or new biopsy before inclusion, and verified locally by a validated method....
Evidence Level:Sensitive: C2 – Inclusion Criteria
New
Title:
A Study of Sotorasib (AMG 510) in Participants With Stage IV NSCLC Whose Tumors Harbor a KRAS p.G12C Mutation in Need of First-line Treatment
Excerpt:...- Pathologically documented metastatic NSCLC with KRAS G12C mutation (local confirmation)...
Evidence Level:Sensitive: C2 – Inclusion Criteria
New
Title:
RW Efficacy of Sotorasib in KRAS G12C-mutated Metastatic NSCLC
Excerpt:...- Presence of KRAS G12C mutation diagnosed on tumor sample and/or on liquid biopsy (co mutations allowed)...
Evidence Level:Sensitive: C2 – Inclusion Criteria
New
Title:
Expanded Access of Sotorasib
Excerpt:...- Pathologically documented, locally-advanced and unresectable or metastatic Non Small-Cell Lung Cancer (NSCLC) with KRAS p.G12C mutation confirmed through molecular testing...
Evidence Level:Sensitive: C2 – Inclusion Criteria
New
Title:
Sotorasib in KRAS G12C Mutated, Resectable, Stage Ib-IIIA NSCLC
Excerpt:...Patients must have non-squamous NSCLC with KRAS G12C mutation identified through molecular testing (local assessment), AJCC 8 stages Ib, IIa, IIb, IIIa (single nodal station) and assessment by a thoracic surgeon that the patient is potentially resectable and physiologically operable....
Evidence Level:Sensitive: C2 – Inclusion Criteria
New
Title:
Sotorasib in Previously Treated Locally Advanced or Metastatic NSCLC Subjects With Mutated KRAS p.G12C
Excerpt:...- Pathologically documented, previously treated, locally-advanced and unresectable or metastatic NSCLC with KRAS p.G12C mutation confirmed through molecular testing (results of both tissue and liquid biopsy are accepted);...
Evidence Level:Sensitive: C2 – Inclusion Criteria
New
Title:
An Open-label, Phase 2trial of Sotorasib in KRAS G12C-mutant Non-small-cell Lung Cancer(NSCLC) Patients and a Translational Study to Find Acquired Resistance Mechanism to Sotorasib
Excerpt:...have documentation of KRAS p.G12C mutation confirmed by local testing through the current protocol or have documentation of KRAS p.G12C mutation prior to enrollment....
Evidence Level:Sensitive: C2 – Inclusion Criteria
New
Title:
Study to investigate JAB-3312 Combination Therapies in Adult Patients with Advanced Solid Tumors
Excerpt:...Advanced NSCLC with KRAS G12C mutationsii. ...
Evidence Level:Sensitive: C2 – Inclusion Criteria
New
Title:
Clinical study to investigate the safety, efficacy and pharmacokinetics of sotorasib in Subjects with Non-Small Cell Lung Cancer
Excerpt:...Pathologically documented, metastatic NSCLC with KRAS p.G12C mutation identified through molecular testing. ...
Evidence Level:Sensitive: C2 – Inclusion Criteria
New
Title:
SHERLOCK: Phase 2 trial of sotorasib in combination with carboplatin-pemetrexed and bevacizumab-biosimilar as first line treatment for advanced non-squamous non-small cell lung cancernwith KRAS G12C mutationn
Excerpt:...Presence of KRAS G12C mutation in tumour tissue ...
Evidence Level:Sensitive: C2 – Inclusion Criteria
New
Title:
Master Protocol of Sotorasib (AMG 510) in Subjects with Advanced Solid Tumors With KRAS p.G12C Mutation (CodeBreaK 101)
Excerpt:...For the full list of inclusion criteria please refer to section 5.1 of the of the subprotocols.All subprotocolsMeasurable disease per RECIST 1.1 criteria Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 2Life expectancy of > 3 months, in the opinion of the investigatorAbility to take oral medications and willing to record daily adherence to investigational productCorrected QT interval (QTc) ≤ 470 msec for women and ≤ 450 msec for men (based on average of screening triplicatesAdequate hematological laboratory assessments, as follows:•Absolute neutrophil count (ANC) ≥ 1.5 x 109/L•Platelet count ≥ 100 x 109/L•Hemoglobin ≥ 9 g/dLAdequate renal laboratory assessments, as follows:•Estimated glomerular filtration rate based on Modification of Diet in Renal Disease (MDRD) calculation ≥ 60 ml/min/1.73 m2•Adequate coagulation laboratory assessments as follows: •PT or PTT or activated partial thromboplastin time ≤ 1.5 x ULN, OR (INR) ≤ 1.5 x ULN or within target range if on prophylactic anticoagulation therapy.Subprotocol F •Pathologically documented, locally-advanced or metastatic NSCLC with KRAS p.G12C mutation identified through molecular testing. ...
Evidence Level:Sensitive: C2 – Inclusion Criteria
New
Title:
An Interventional and Translational Study investigating Sotorasib in Previously Treated Locally Advanced or Metastatic non-small-cell lung cancer
Excerpt:...- Age ≥ 18 years;- ECOG ≤ 1 at the time of screening;- Pathologically documented, previously treated, locally-advanced and unresectable or metastatic NSCLC with KRAS p.G12C mutation confirmed through molecular testing (results of both tissue and liquid biopsy are accepted);- Subjects will have progressed or experienced disease recurrence on or after receiving at least 1 prior systemic therapy for locally advanced and unresectable or metastatic disease. ...
Less C2 evidence
Evidence Level:Resistant: C3 – Early Trials
Title:
Clinical characteristics and prognostic value of the KRAS G12C mutation in Chinese non-small cell lung cancer patients
Excerpt:The PFS benefit of intercalated use of gefitinib over placebo was more apparent for patients with EGFR-mutant tumors (13.3 vs. 7.8 months, P = .025) than those with EGFR-wild-type tumors (8.2 vs. 6.6 months, P = .063). Overall, there was no difference in the frequency of severe adverse effect between the 2 arms...The KRAS G12C mutation is a biomarker of poor prognosis in Chinese NSCLC patients, which could potentially be improved by G12C-specific inhibitors in the future.(296 words).
DOI:10.1186/s40364-020-00199-z