New drug combo shows promise for tough lung cancer
NCT ID NCT03083041
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested a combination of two drugs, SHR-1210 (given through a vein) and Apatinib (a daily pill), in 210 adults with advanced non-small cell lung cancer that had stopped responding to standard chemotherapy. The goal was to see if the combo could shrink tumors and to check for side effects. Participants received one of two doses of Apatinib along with SHR-1210, and their tumors were monitored over time.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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210 people
The number who actually took part.
- Started
-
Mar 2017
- Finished
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Apr 2022
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 70 years
- Sex
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Subjects \>/= 18 years and \</=70 years of age at the time of Informed Consent. 2. Advanced relapsed or refractory predominantly NSCLC with at least one measurable lesion according to RECIST 1.1. 3. Failure of second line of chemotherapy(Part 1); Failure of First line of chemotherapy(Part 2) 4. Eastern Cooperative Oncology Group (ECOG) performance status 0-1. 5. Patients must have recovered from any AEs of prior treatments before randomization. 6. Adequate bone marrow,liver and renal function as assessed by the following laboratory tests conducted within 1 week before randomization. HB ≥ 90g/L; ANC≥1.5×10E+9/L; PLT≥100×10E+9/L; ALT and AST \< 1.5×ULN; TBIL ≤1×ULN; Cr ≤1.5×ULN or CL≥60 ml/min. 7. Life expectancy of at least three months. 8. Male or female participants of childbearing potential must be willing to use an adequate method of contraception starting with the first dose of study drug through 60 days for female subjects and 120 days for male subjects after the last dose of study drug. 9. Written informed consent and the willingness and ability to comply with all aspects of the protocol. Exclusion Criteria: 1. Suffered from grade II or above myocardial ischemia or myocardial infarction, uncontrolled arrhythmias (including QT interval male ≥ 450 ms, female≥ 470 ms). 2. Severe or uncontrolled systemic disease such as clinically significant hypertension (systolic pressure \>/= 140 mm Hg and/or diastolic pressure \>/= 90 mm Hg), and Grade III-IV cardiac insufficiency, according to NYHA criteria or echocardiography check: LVEF\<50%. 3. Factors to affect oral administration (inability to swallow tablets,GI tract resection, chronic bacillary diarrhea and intestinal obstruction). 4. Coagulation disfunction,hemorrhagic tendency or receiving anticoagulant therapy 5. \>/= CTCAE 2 pneumorrhagia or \>/= CTCAE 3 hemorrhage in other organs within 4 weeks. 6. Bone fracture or wounds that was not cured. 7. Arterial thrombus or phlebothrombosis within 6 months and taking anticoagulant agents. 8. Mental diseases and psychotropic substances abuse. 9. Previous treatment with an trial agent within 4 weeks 10. Proteinuria ≥ (++) or 24 hours total urine protein \> 1.0 g. 11. Other coexisting malignant disease (except basal-cell carcinoma and carcinoma in situ of uterine cervix).
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, 200433, China
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