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New treatment option for Non-small Cell Lung Cancer
Official title Osimertinib Combined With Chemotherapy in Patients Who Had Distant Recurrence After Adjuvant Osimertinib for EGFRm Resectable SIB-IIIA NSCLC.
ClinicalTrials.gov ID: NCT07279935
What this study is testing
What is Osimertinib+cisplatin or carboplatin + pemetrexed Edit?
Osimertinib+cisplatin or carboplatin + pemetrexed Edit is an investigational medicine, given as an once-daily, being studied as a potential treatment for non-small cell lung cancer.
Also referred to as Cohort1.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is designed as a multi-cohort trial based on various patient biomarkers study with the potential to include new study treatment in the future. EGFR-sensitive mutation-positive patients with distant recurrence after adjuvant osimertinib treatment for EGFRm resectable SIB-IIIA NSCLC and scheduled to receive osimertinib plus chemotherapy will be enrolled in cohort 1.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- for pre-screening:
- Prior complete surgical resection (R0) and adjuvant osimertinib in EGFRm resectable SIB-IIIA NSCLC (AJCC 7th edition).
- Off-treatment recurrence (including completed 3 years adjuvant osimertinib \& discontinued adjuvant osimertinib before 3 years due to non-recurrence...
- Newly diagnosed distant recurrent NSCLC (IVA or IVB) (per Version 9 of the International Association for the Study of Lung Cancer [IASLC] Staging...
- ≥6 months interval between recurrence and completion or discontinuation of adjuvant osimertinib.
You likely can't join if
- Patients with only local/regional recurrence.
- Spinal cord compression and symptomatic brain metastases.
- Past medical history of ILD, drug-induced ILD, radiation pneumonitis that required steroid treatment, or any evidence of clinically active ILD.
- Adjuvant osimertinib therapy was discontinued due to the occurrence of severe adverse events.
- Prior with other adjuvant EGFR-TKIs (excluding osimertinib).
- Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel...
See the full eligibility criteria
- for pre-screening:
- Prior complete surgical resection (R0) and adjuvant osimertinib in EGFRm resectable SIB-IIIA NSCLC (AJCC 7th edition).
- Off-treatment recurrence (including completed 3 years adjuvant osimertinib \& discontinued adjuvant osimertinib before 3 years due to non-recurrence reason).
- Newly diagnosed distant recurrent NSCLC (IVA or IVB) (per Version 9 of the International Association for the Study of Lung Cancer [IASLC] Staging Manual in Thoracic Oncology).
- ≥6 months interval between recurrence and completion or discontinuation of adjuvant osimertinib.
- Histologically/cytologically confirmed nonsquamous NSCLC (Investigators confirmed recurrence of primary lesion allowed if biopsy not available)
- No prior systemic anti-cancer therapy after adjuvant therapy, but can receive local therapy (including surgery, radiotherapy, etc. per investigator choice).
- Patients with asymptomatic or stable CNS metastases allowed. for screening:
- Male or female, at least 18 years of age. Type of patient and disease characteristics
- EGFR mutation (Exon 19del/Exon 21 L858R)-reconfirmed for study entry (mandatory undergo NGS by plasma, and tissue if applicable).
- Life expectancy \>12 weeks at Day 1.
- Patients with only local/regional recurrence.
- Spinal cord compression and symptomatic brain metastases.
- Past medical history of ILD, drug-induced ILD, radiation pneumonitis that required steroid treatment, or any evidence of clinically active ILD.
- Adjuvant osimertinib therapy was discontinued due to the occurrence of severe adverse events.
- Prior with other adjuvant EGFR-TKIs (excluding osimertinib).
- Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection that would preclude adequate absorption of osimertinib.
- History of hypersensitivity to active or inactive excipients of osimertinib or drugs with a similar chemical structure or class to osimertinib.
- Contraindication for pemetrexed and cisplatin/carboplatin according to local approved label.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, China
- Chengdu, China
- Chongqing, China
- Fuzhou, China
- Guangzhou, China
- Hangzhou, China
- Hefei, China
- Jinan, China
- Kunming, China
- Nanchang, China
- Nanjing, China
- Ningbo, China
- Shanghai, China
- Shenyang, China
- Tianjin, China
- Wuhan, China
- Xi'an, China
- Zhengzhou, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, China; Chengdu, China; Chongqing, China; Fuzhou, China; Guangzhou, China; Hangzhou, China and 12 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.