Combining Dacomitinib and Anlotinib for Advanced Lung Cancer Treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter, open-label study investigates the safety and efficacy of dacomitinib combined with anlotinib as a first-line treatment for patients with advanced non-small cell lung cancer (NSCLC) harboring EGFR 21-L858R mutations. The study consists of two parts: a Phase I dose escalation to determine the optimal dosage and a Phase IIB randomized controlled trial to assess treatment outcomes. Participants will be monitored for response rates and safety profiles throughout the study.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. ≥18 years of age and ≤75 years;
2. Provision of a voluntarily given, personally signed and dated, written informed consent document;
3. Histologically documented, unresectable, inoperable, locally advanced, recurrent or metastatic stage IIIB or IV non-small cell lung cancer (NSCLC);
4. It is acceptable for subjects with the presence of EGFR activating mutation (exon 19 deletion and the L858R mutation in exon 21) to be included in this Phase I study; Only subjects with the L858R mutation in exon 21 to be included in this Phase IIb;
5. At least one measurable disease by RECIST criteria version 1.1;
6. Patients with controlled or stable brain metastases;
7. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1, and life expectancy of at least 3 months;
8. No prior treatment with systemic therapy for advanced NSCLC, including TCM treatments;
9. Able to comply with required protocol procedures and able to receive oral medications;
10. Adequate organ function, including:

(1) Adequate bone marrow function Hemoglobin≥90g/L, absolute neutrophil count (ANC) should be ≥ 1.5x109/L, platelets should be ≥ 80x109/L; (2) Adequate liver function Total bilirubin ≤ 1.5 x upper normal limit (ULN), Aspartate Aminotransferase (AST) (SGOT) ≤ 2.5 x ULN (≤ 5.0 x ULN if hepatic metastases), Alanine Aminotransferase (ALT) (SGPT) ≤ 2.5 x ULN (≤ 5.0 x ULN if hepatic metastases), Creatinine≤ 1.5 x upper normal limit (ULN), or ≥ 60 mL/min; (3) Cardiac function: LVEF≥50% assessed by Doppler ultrasound；

Exclusion Criteria:

1. Small cell lung cancer (including mixed small cell and non-small cell lung cancer) and squamous cell carcinoma with cavitation;
2. Patients with concurrent EGFR T790M mutation or unknown mutation status or other mutation types;
3. Diagnosis of any other malignancy during the last 5 years, or with other malignancies at present;
4. Patients with pre-existing meningeal metastases;
5. Patients who have concurrent other malignant tumors;
6. Any history of hemoptysis, hematochezia, bloody sputum;
7. Tumor invasion or adjacent major vessels;
8. Patients with uncontrolled or significant systematic disease, including: active infection, thyroid dysfunction, uncontrolled hypertension, unstable angina pectoris, congestive heart failure, or myocardial infarction within 6 months, or severe arrhythmia requiring medication;
9. A history of other diseases, or metabolic dysfunction, or physical examination or laboratory results suggestive of a disease or condition that precludes the use of an investigational drug, or may affect the interpretation of the study results, or expose the patient to a high risk of treatment complications;
10. Any astrointestinal disorders resulting in inability to take medications orally, or requiring intravenous (IV) nutrition, or previous surgery impair drug absorption;
11. Pregnant or lactating females;
12. Patients allergic to any pharmaceutical ingredient.

Where it's running

• Shanghai Chest Hospital
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Study coordinator: Bo Zhang, MD
• Email: zb1063253078@163.com
• Phone: 15800386291

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.