Non-Small Cell Lung Cancer (NSCLC, Locally Advanced or Metastatic, Second-linePhase 2NCT07780578
The Study Of Andamertinib Plus Anlotinib In Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer
A Phase 2 study testing Andamertinib and Anlotinib in people with Non-Small Cell Lung Cancer (NSCLC, Locally Advanced or Metastatic, Second-line, run by Fudan University at 1 site in China.
Trial summary
This study is a single arm study to access the anti-tumor efficacy and safety of Andamertinib plus Anlotinib in patients with locally advanced or metastatic non-small cell lung cancer previously treated with third-generation EGFR-TKI. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small Cell Lung Cancer (NSCLC, Locally Advanced or Metastatic, Second-line
- What is being tested?
- Andamertinib and Anlotinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteChina
- Study dates
- 30 Sep 2026to 30 Sep 2029
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able to understand and voluntarily sign the written informed consent form.
- Aged ≥ 18 years, male or female.
- Non-small-cell lung cancer (NSCLC) confirmed histologically or cytologically, clinically diagnosed as unresectable and ineligible for curative concurrent chemoradiotherapy, including locally advanced (stage ⅢB/ⅢC), metastatic or recurrent (stage Ⅳ) NSCLC.
- Harboring EGFR mutations (including exon19 deletions and exon21 L858R mutation), with documented disease progressed following only one prior line of third-generation EGFR-TKI therapy.
- At least one measurable lesion per RECIST v1.1. Lesions previously irradiated cannot serve as target lesions unless definitive progression has occurred in the irradiated lesion.
- Patients with asymptomatic brain metastases, or brain metastases whose symptoms have stabilized after treatment.
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- Laboratory values meeting all of the following criteria:
- Hemoglobin ≥100g/L (female), ≥110g/L (male). (2) Absolute neutrophil count ≥1.5×10⁹/L. (3) Platelet count ≥100×10⁹/L. (4) Serum creatinine ≤115 μmol/L, or creatinine clearance (CrCl) ≥60mL/min (Cockcroft-Gault formula).
- Total bilirubin ≤1.5×upper limit of normal (ULN). (6) Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3×ULN; or ≤5×ULN for patients with liver metastases.
- Albumin ≥30g/L. 8. ECOG PS 0-1. 9. Expected survival ≥3 months. 10. Males with reproductive potential and females of child-bearing potential must agree to use effective contraception from the time of informed consent signing until 3 months after the last study drug administration. For females of child-bearing potential, serum pregnancy test must be negative within 7 days prior to the first study drug dose. Women with surgical sterilization or post-menopausal status are exempted.
Who cannot join
- Diagnosis of other malignant diseases within 3 years prior to first study drug administration, except for radically treated basal cell carcinoma of the skin, squamous-cell carcinoma of the skin, and/or radically resected carcinoma in-situ.
- Presence of any of the following genetic alterations: ALK fusion, ROS1 fusion, BRAF V600 mutation, NTRK fusion, MET exon14 skipping mutation, MET amplification, RET fusion, KRAS G12C mutation, HER2 mutation, NRG1 fusion.
- Central squamous-cell carcinoma with high risk of massive hemoptysis.
- Toxicities from prior anti-tumour therapy have not recovered to Grade≤1, except for alopecia, fatigue and other toxicities judged by the investigator to carry low safety risk.
- Prior treatment with sunvozertinib.
- Major surgery (e.g., intrathoracic, intra-abdominal or pelvic surgery) within 4 weeks before first study drug administration, or resection for brain metastases within 2 weeks, with incomplete recovery from surgical adverse effects. Thoracoscopic biopsy and mediastinoscopy are not considered major surgery; subjects may be enrolled ≥1week after such procedures. Thoracic/abdominal effusion drainage and needle biopsy are not regarded as surgery.
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- Severe or uncontrolled systemic diseases, including but not limited to:
- Uncontrolled hypertension (systolic blood pressure >160 mmHg and/or diastolic blood pressure >100 mmHg despite treatment; antihypertensive agents may be initiated or adjusted prior to screening).
- Positive HIV antibody; or positive HCV antibody plus positive HCV-RNA; or positive HBsAg with HBV-DNA ≥500 IU/mL. Exception: subjects may be enrolled if HBV-DNA decreases to < 500 IU/mL and remains so for ≥2 weeks under antiviral therapy during screening, and antiviral therapy must be continued throughout the study. Subjects who require antiviral therapy at screening or in the past must maintain antiviral therapy for the whole study period.
- Active keratitis or ulcerative keratitis. (4) Active tuberculosis. (5) Active infection requiring systemic anti-infective therapy within 2 weeks prior to first study drug administration.
- Other severe physical or psychiatric illnesses or laboratory abnormalities that, in the investigators opinion, make study drug inappropriate or compromise protocol compliance.
- 8. Any of the following cardiac conditions:
- Mean QTcF (QTc corrected by Fridericia formula) from three screening ECGs >470 ms at rest.
- Significant arrhythmias including ventricular arrhythmias, pharmacologically uncontrolled supraventricular/nodal arrhythmias and other uncontrolled cardiac arrhythmias (e.g., complete left bundle-branch block, grade III atrioventricular block, grade II atrioventricular block, PR interval >250 msec).
- Risk factors for QTc interval prolongation: e.g., severe hypokalaemia, congenital long-QT syndrome, concomitant use of QTc-prolonging drugs.
- New York Heart Association (NYHA) congestive heart failure class ≥3; left ventricular ejection fraction (LVEF) <50% on echocardiogram.
- 9. History of interstitial lung disease, drug-induced interstitial lung disease, or radiation pneumonitis requiring steroid therapy; or ongoing medical intervention or active interstitial lung disease at present.
- 10. Coagulopathy or bleeding diathesis: arterial/venous thromboembolic events within 6 months before first study drug administration (including myocardial infarction, unstable angina, cerebrovascular accident or transient ischaemic attack, pulmonary embolism, severe deep-vein thrombosis or other serious thromboembolic events); life-threatening bleeding events requiring transfusion, surgery, local intervention or sustained medical treatment; or tumour invasion of major vessels judged by the investigator to confer high bleeding risk.
- 11. Dysphagia, active gastrointestinal disorders, or history of major gastrointestinal surgery that may substantially impair study-drug ingestion or absorption (e.g., ulcerative lesions, inability to swallow oral medication, uncontrolled nausea, vomiting, diarrhoea, malabsorption syndrome).
- 12. Pleural, pericardial or peritoneal effusion requiring drainage and/or associated with dyspnoea within 4 weeks before first study drug administration.
- 13. Any clinically significant systemic disease requiring treatment as judged by the investigator, including but not limited to thyroid disorders (subjects with stable thyroid function on hormone-replacement therapy are eligible), organ transplantation recipients, psychiatric disorders, history of substance abuse, alcoholism or drug addiction.
- 14. Known hypersensitivity to the active substance or excipients of the study drug.
- 15. Pregnant or lactating females. 16. Currently participating in another investigational drug or device trial, or having received other investigational drugs/devices within 2 weeks before first study drug administration.
- 17. Cognitive impairment likely to limit understanding and execution of informed consent.
- 18. Any other conditions that may increase risks related to study-drug administration, confound interpretation of study results, poor subject compliance, or render the subject unsuitable for enrolment as judged by the investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Fudan University Shanghai Cancer Center
Shanghai
Jialei Wang, 18017312369, wangjialei@shca.org.cn
About this study
Official title: A Single Arm, Multicenter, Phase II Clinical Study to Evaluate the Efficacy and Safety of Andamertinib Combined With Anlotinib in Patients With Locally Advanced or Metastatic Non Small Cell Lung Cancer Who Failed Prior First Line Third Generation EGFR TKI Therapy
This study is a single arm study to access the anti-tumor efficacy and safety of Andamertinib plus Anlotinib in patients with locally advanced or metastatic non-small cell lung cancer previously treated with third-generation EGFR-TKI.
- Being tested
- Andamertinib, Anlotinib
- Keywords
- Andamertinib, Anlotinib, Third-generation EGFR-TKI, Non-Small Cell Lung Cancer
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AndamertinibDrug
Andamertinib: 160mg, QD, Q3W
AnlotinibDrug
Anlotinib: 12mg/10mg, QD, d1-d14, Q3W
| Study group | Role | What they receive |
|---|---|---|
| Andamertinib + Anlotinib | Experimental | Not described Receives: Drug: Andamertinib; Drug: Anlotinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
Progression-free survival (PFS per RECIST 1.1) is defined as the time from treatment to the date of first documentation of disease progression or death, whichever occurs first
Measured: 12 months after the last subject participating in
Secondary outcomes (5)
ORR
The proportion of subjects with complete response (CR) and partial response (PR) in total subjects
Measured: 12 months after the last subject participating in
DCR
The proportion of subjects with complete response (CR), partial response (PR)and stable disease in(SD) in total subjects
Measured: 12 months after the last subject participating in
DoR
DoR (per RECIST 1.1) is defined as the time from the date for first documented response of complete response (CR) or partial response (PR) to the date of first documented of disease progression or death, whichever occurs first.
Measured: 12 months after the last subject participating in
OS
Defined as the time from treatment to all-cause death
Measured: 24 months after the last subject participating in
The incidence of Subjects With Treatment-Emergent Adverse Event (TEAE)
TEAE will be defined as the adverse events (AEs) that occur between first dose of study drug administration and 28 days after the last dose of study drug administration that were absent before treatment or that worsened relative to pretreatment state.
Measured: 24 months after the last subject participating in
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2026
- Study start30 Sep 2026 (estimated)
- Primary completion30 Sep 2028 (estimated)
- Study completion30 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-Small Cell Lung Cancer (NSCLC, Locally Advanced or Metastatic, Second-lineStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jialei Wang, Fudan University
- Investigators
- Jialei Wang, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07780578
- Sponsor's protocol ID
- PLB1004-IIT-NSCLC-1
- Status last verified
- Aug 2026
- First submitted
- 19 Aug 2026
- Last updated
- 25 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
[1] Li K, Yang M, Liang N, et al. Determining EGFR-TKI sensitivity of G719X and other uncommon EGFR mutations in non-small cell lung cancer: Perplexity and solution (Review)[J]. Oncol. Rep., 2017, 37(3): 1347-1358. [2] NCCN Clinical Practice Guidelines in Oncology, Non-Small Cell Lung Cancer, Version 3.2022 [3] Chinese Society of Clinical Oncology (CSCO) Guidelines for the Diagnosis and Treatment of Non-Small-Cell Lung Cancer (2022 Edition) [4] Cheng Y, He Y, Li W, et al. Osimertinib versus comparator EGFR TKI as first-line treatment for EGFR-mutated advanced NSCLC: FLAUA China, a randomized study. Target Oncol, 2021, 16(2): 165-176. doi:10.1007/s11523-021-00794-6. [5] Hua-Jun Chen，Hai-Yan Tu，Yi-Long Wu et al. A phase II trial of anlotinib plus EGFR-TKIs in advanced non-small cell lung cancer with gradual, oligo, or potential progression after EGFR-TKIs treatment (CTONG-1803/ALTER-L001)，Journal of hematology & oncology, 2025 Jan 5;18(1):3. doi: 10.1186/s13045-024-01656-0. [6] Yu Hua，Minghui Liu，Jun Chen et al. Anlotinib Plus Osimertinib in Osimertinib-Resistant Nonsquamous Nonsmall Cell Lung Cancer With Gradual Progression: A Retrospective Study，Thoracic cancer, 2025 May;16(10):e70071. doi: 10.1111/1759-7714.70071.