Clinical trial · Interventional
A Trial of Anlotinib Combined With Concurrent Chemoradiotherapy in Patients With Unresectable Stage III Non-small Cell Lung Cancer
A Phase I/II Clinical Study of Anlotinib Hydrochloride Capsule Combined With Concurrent Chemoradiotherapy in the Treatment of Unresectable Stage III Non-small Cell Lung Cancer
NCT04958993CI-TRIAL-00056745terminatedPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): High incidence of severe radiation pneumonia
Summary
Brief summary (as posted)
This is a phase I/II exploratory study to evaluate the efficacy and safety of anlotinib combined with concurrent chemoradiotherapy in the treatment of surgically unresectable stage III non-small cell lung cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Anlotinib hydrochloride capsule Combined With Concurrent Chemoradiotherapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Anlotinib combined with concurrent chemoradiotherapy
- description
- Radiotherapy: 1.8-2.0Gy, qd, 54-66Gy, 5 days a week Chemotherapy: squamous cell cancer: paclitaxel + platinum;Adenocarcinoma: pemetrexed + platinum;A cycle of 3W was used, and the appropriate chemotherapy dose was selected by the researcher according to the patient's situation without any restriction on the chemotherapy dose.Pre-induction chemotherapy is allowed. Anlotinib: QD, take 2 weeks and stop for 1 week (radiotherapy 1, 2, 4, 5 weeks)
- interventionNames
- Drug: Anlotinib hydrochloride capsule Combined With Concurrent Chemoradiotherapy
Primary outcomes (2)
- measure
- Progress free survival (PFS) for phase Ⅱ
- timeFrame
- up to 30 months
- description
- PFS defined as the time from first dose of study treatment until the first date of either objective disease progression or death due to any cause.
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * 1\. The patients volunteered to participate in this study and signed the informed consent; * 2\. Locally advanced (IIIA/IIIC) non-small cell lung cancer patients diagnosed by pathology as newly diagnosed unresectable, inoperable or refused surgery (difficult patients should be evaluated by thoracic multidisciplinary assessment for potential enrollment); . * 3\. Ages 18-75, regardless of gender; * 4\. ECOG score: 0-1; * 5\. Expected survival over 3 months; * 6\. Function of major organs within 7 days prior to treatment meets the following criteria: A. Standard of blood routine examination (without blood transfusion within 14 days) : I. Hemoglobin (HB) ≥100 g/L; II. WBC ≥3.0×109/L; Iii. Platelet (PLT) ≥100×109/L. B. Biochemical examination shall meet the following standards: I. Total bilirubin (TBIL) ≤1.5 times the upper limit of normal value (ULN); II. AST≤2.5×ULN of alanine aminotransferase (ALT) and aspartate aminotransferase (ASpartate), if accompanied by liver metastasis, ALT and AST≤5×ULN; III. Serum creatinine (Cr) ≤1.5×ULN or creatinine clearance rate (CCr)≥60ml/min; C. Doppler ultrasound evaluation: left ventricular ejection fraction (LVEF) ≥ lower normal limit (50%); D. Pulmonary function assessment: FEV1≥1.45 l/s. * 7\. Patients of childbearing age (including female and female partners of male patients) must take effective birth control measures Exclusion Criteria: * 1\. Patients who have previously used anlotinib hydrochloride capsules; * 2\. Small cell lung cancer (including mixed small cell and non-small cell cancers); * 3\. Lung squamous cell carcinoma with empty cavity, or non-small cell lung cancer with hemoptysis (\> 20ml/day); * 4\. Patients with other malignant tumors other than NSCLC within 5 years before the start of treatment in this study (except those with simple surgical resection and disease-free survival for at least 5 consecutive years, cured cervical carcinoma in situ, cured basal cell carcinoma and bladder epithelial tumor); * 5\. Systemic antitumor therapy, including cytotoxic therapy, signal transduction inhibitors and immunotherapy, is planned within 4 weeks before enrollment or during the medication period of this study.In addition to thymosin, lentinan and other immunomodulator treatment. * 6\. Unmitigated toxicity due to any previous treatment above CTC AE level 1, excluding hair loss; * 7\. Patients with multiple factors affecting oral medication (such as inability to swallow, chronic diarrhea and intestinal obstruction); * 8\. Accompanied by pleural effusion or ascites, causing respiratory syndrome (≥CTC AE level 2 dyspnea); * 9\. Patients with any severe and/or uncontrolled disease, including: A) Patients with unsatisfactory blood pressure control (systolic blood pressure ≥150 mmHg, diastolic blood pressure ≥100 mmHg); B) Having grade I or above myocardial ischemia or infarction, arrhythmia (including QTc ≥480ms), and grade 2 or above congestive heart failure (New York Heart Association (NYHA) classification); C) Active or uncontrolled severe infection (≥CTC AE level 2 infection); D) Antiviral treatment for cirrhosis, decompensated liver disease, active hepatitis or chronic hepatitis; E) Renal failure requires hemodialysis or peritoneal dialysis; F) A history of immunodeficiency, including HIV positive or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation; G) poor control of diabetes mellitus (FBG) \> 10mmol/L; H) urine routine indicated urinary protein ≥++, and confirmed 24-hour quantitative urinary protein \> 1.0g; I) patients with epileptic seizures requiring treatment; J) Patients with gastric ulcer * 10\. Receive major surgical treatment, open biopsy or significant traumatic injury within 28 days before grouping; * 11\. Patients whose tumors have invaded important blood vessels according to imaging findings or whose tumors are likely to invade important blood vessels during the follow-up study according to the judgment of the researchers, resulting in fatal massive hemorrhage; * 12\. Patients with any physical signs or history of bleeding, regardless of severity;Patients with any bleeding or bleeding event ≥CTCAE level 3 within 4 weeks prior to enrollment have unhealed wounds, ulcers or fractures; * 13\. Occurrence of ARTERIAL/venous thrombotic events, such as cerebrovascular accidents (including temporary ischemic attacks), deep venous thrombosis and pulmonary embolism within 6 months; * 14\. Persons with a history of abuse of psychotropic substances and who cannot be cured or have mental disorders; * 15\. Pregnant and lactating women; * 16\. Participated in other clinical trials of anti-tumor drugs within 4 weeks; * 17\. The researcher considered that there were other conditions that were not suitable for inclusion.
References
Publications (0)
Data not yet available
No reference posted for this study.