NSCLC
Conditions
Interventions
Observation group:NA
Sponsors
Shanghai Gobroad Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. 2. Provision of signed and dated, written informed consent form prior to any mandatory study specific procedures, sampling, and analyses. 3. Male or female, age at least 18 years. 4. Pathologically confirmed non-squamous non-small cell lung cancer (NSCLC) with documented EGFR sensitive mutation (EGFR 19del and L858R) positive before 1L Osimertinib plus chemotherapy. 5. Locally advanced (clinical stage IIIB, IIIC) or metastatic NSCLC(clinical stage IVA or IVB) or recurrent NSCLC (per Version 8 of the International Association for the Study of Lung Cancer [IASLC] Staging Manual in Thoracic Oncology) which is at the start of Osimertinib plus chemotherapy. 6. Participants must have been treated with Osimertinib combined with chemotherapy as first line therapy until disease progression. Evidence of disease progression following 1L Osimertinib combined with chemotherapy can be confirmed by investigators (referring to RECIST 1.1 criterion). Participants must have initiated both chemotherapy and Osimertinib as first-line therapy within a <=90-day interval, with no evidence of disease progression between treatment initiations. 7. Agree to provide adequate tissue samples (Mandatory) and whole blood samples (optional) for testing after disease progression following 1L Osimertinib plus chemotherapy and before the start of the second-line anti-cancer treatment. Agree to provide adequate tissue sample (optional) for testing before 1L Osimertinib plus chemotherapy treatment. 8. Female participants who are not abstinent (in line with the preferred and usual lifestyle choice of the participant) and intend to be sexually active with a male partner must be using highly effective contraceptive measures, must not be breast feeding, and must have a negative pregnancy test prior to the enrolment.
Exclusion criteria
Exclusion criteria: 1. Any concurrent and/or other active malignancy that may affect tissue or whole blood testing results. 2. As judged by the investigator, any evidence of severe or uncontrolled systemic diseases, which in the investigator’s opinion, makes it undesirable for the participant to participate in the study or that would jeopardise compliance with the protocol. Screening for chronic conditions is not required. 3. Any other anti-cancer treatment (such as bevacizumab, et al) during the first line treatment, except local treatments. 4. Judgment by the investigator that the participant should not participate in the study if the participant is unlikely to comply with study procedures, restrictions and requirements.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Gene profile of resistance after disease progression (FAS set);Acquired resistance molecule;Number and percentage of participants with different gene alteration by NGS; | — |
Secondary
| Measure | Time frame |
|---|---|
| MET Expression;Subsequent treatment regimens (FAS set); | — |
Countries
China
Contacts
Public ContactShuang Li
Shanghai Gobroad Cancer Hospital
Outcome results
None listed