At a glance
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An Open-label, Multicenter Phase Ib/II Clinical Study to Evaluate the Safety, Efficacy, and Pharmacokinetic of PLB1004 Capsules Combined With Platinum-based Doublet Chemotherapy in Patients With EGFR Mutation-positive NSCLC
In Brief
A Phase 2 clinical trial evaluating PLB1004 80mg/160mg/240mg oral once daily Combined with Platinum-Based Chemotherapy and RP2D of PLB1004 oral once daily Combined with Platinum-Based Chemotherapy for NSCLC (Non-small Cell Lung Cancer). Not yet recruiting, targeting 108 participants across 1 site.
Detailed Summary
Tyrosine Kinase Inhibitor (TKI) that targets Epidermal Growth Factor Receptor (EGFR) mutations. Unfortunately, despite the benefit observed for patients treated with EGFR-TKI, the vast majority of cancers are expected to develop resistance to the drug over time. The exact reasons why resistance develops are not fully understood but based upon clinical research it is hoped that combining PLB1004 with another type of anti-cancer therapy known as chemotherapy will delay the onset of resistance and the worsening of a patient's cancer. In recent years, clinical studies on the combination of EGFR-TKI and chemotherapy have made important progress, suggesting that the combination of EGFR-TKI and chemotherapy further enhances the therapeutic benefit in EGFR-mutant positive NSCLC. Both preclinical and clinical data indicate that PLB1004 exhibit good antitumor activity and relatively durable efficacy in NSCLC patients with EGFR mutations. They can reduce tumor burden, control tumor progression, and improve the survival benefit of patients, which is expected to provide an effective treatment option for such patients.
Study Details
Timeline
Interventions
For non-squamous NSCLC patients：Pemetrexed (500 mg/m2) plus carboplatin (AUC5) or cisplatin（75 mg/m²）on Day 1 of 21day cycles (every 3 weeks) , followed by PLB1004 80mg/160mg/240mg oral once daily。 For squamous NSCLC subjects: Docetaxel（75 mg/m² ）or paclitaxel（175 mg/mg） plus carboplatin (AUC5) or cisplatin（75 mg/m²）on Day 1 of 21day cycles (every 3 weeks) , followed by PLB1004 80mg/160mg/240mg oral once daily.
Multiple doses of PLB1004 for oral administration. Platinum-based chemotherapy is combined and administered on Day 1 of 21days（every 3 weeks).
RP2D of PLB1004 as determined during Phase Ib . Platinum-based chemotherapy is combined and administered on Day 1 of 21days（every 3 weeks）.
RP2D of PLB1004 as determined during Phase Ib，patients will undergo surgical treatment after 3 cycles of combination therapy with platinum-based chemotherapy. Post-surgery, they will receive an additional cycle of platinum-based chemotherapy followed by 13 cycles of maintenance therapy with PLB1004.