| Eligibility |
Inclusion Criteria:
- Signed and dated informed consent
- Non Small cell lung cancer pathologically confirmed, with measurable nidus (RECIST
1.1)
- Disease progression following prior Immune Checkpoint Inhibitors (PD-1 or PD-L1
inhibitors) treatment for NSCLC for at least 2 consecutive treatment cycles.
- EGFR/ALK/ROS1 wild type
- ECOG PS: 0-1, Expected Survival Time: Over 3 months
- Adequate bone marrow, liver and renal function
- The woman patients of childbearing age who must agree to take contraceptive methods
(e.g. intrauterine device, contraceptive pill or condom) during the research and
within another 8 weeks after it; who are not in the lactation period and examined as
negative in blood serum test or urine pregnancy test within 7 days before the
research; The man patients who must agree to take contraceptive methods during the
research and within another 8 weeks after it.
Exclusion Criteria:
- Small Cell Lung Cancer (including small cell cancer and other kinds of cancer mixed
with non small cell cancer)
- Have used Anlotinib or other antiangiogenic drugs before
- Known primary multidrug resistance to prior ICIs treatments
- Have failed for two times or beyond of platinum two drugs chemotherapy (except
adjunctive chemotherapy, neoadjuvant therapy and concurrent chemoradiotherapy
- Iconography (CT or MRI) shows obvious lung empty or necrotic tumor iconography (CT or
MRI) shows that the tumor vessels have 5 mm or less, or Cardiovascular involvement by
Central tumor; Or obvious lung empty or necrotic tumor
- Patients with brain or central nervous system metastases, including leptomeningeal
disease, or CT/MRI examination revealed brain or leptomeningeal disease) (28 days
before the random treatment has been completed and the symptoms of patients with brain
metastases from stable can into the group, but need to the cerebral MRI, CT or vein
angiography confirmed as without symptoms of cerebral hemorrhage)
- Patients are participating in other clinical studies (other than non-interventional
studies) less than 4 weeks from the end of the previous clinical study
- Patients who had received chemotherapy, radiation, or other experimental anticancer
therapy (except Diphosphonate) within 4 weeks prior to the first dose of this study.
Those who had previously received local radiotherapy were eligible if they met the
following criteria: the end of radiotherapy was more than 4 weeks from the start of
this study (brain radiotherapy was more than 2 weeks); In addition, the target lesions
selected in this study were not in the radiotherapy area, or if the target lesion is
within the radiotherapy area but progression has been confirmed
- Other kinds of malignancies within 5 years or for now
- Patients who have an active, known or suspected autoimmune disease, including a
history of allogeneic organ transplantation, allogeneic hematopoietic stem cell
transplantation, a history of being HIV positive, or a history of acquired
immunodeficiency syndrome (AIDS)
- Active or previously recorded inflammatory bowel disease (such as Crohn's disease,
ulcerative colitis)
- Have got non remissive toxic reactions derived from previous therapies, which is over
level 1 in CTC AE (4.0), alopecia NOT included
- Abnormal coagulation (INR > 1.5 or prothrombin time (PT) > ULN + 4 seconds or APTT ULN
> 1.5), with bleeding tendency or be treated with thrombolysis and anticoagulation
- Have clinical significant hemoptysis occurred within 3 months before enrollment (daily
hemoptysis more than half tablespoonl; Or clinical significant bleeding symptoms or
bleeding tendency in the 4 weeks prior to grouping, such as gastrointestinal bleeding,
hemorrhagic gastric ulcer (including gastrointestinal perforation and/or fistula, but
gastrointestinal perforation or fistula has been surgically removed, admission is
allowed), baseline fecal occulted blood ++ or above, unhealed wounds, ulcers or
fractures, etc
- Urine routines show urine protein= ++, and urine protein quantity= 1.0 g during 24
hours
- Uncontrollable hypertensive (SBP= 150 mmHg, DBP=100 mmHg, despite the best drug
treatment)
- Patients with severe cardiovascular disease: grade II or above myocardial ischemia or
myocardial infarction, poorly controlled arrhythmia; According to NYHA standard, grade
III to IV cardiac insufficiency, or echocardiography indicates left ventricular
ejection fraction (LVEF) < 50%;
- Patients with NCI-CTCAE grade II or greater peripheral neuropathy, except due to
trauma
- Interstitial lung disease, uncontrolled medium to large serosal effusion (including
pleural effusion, ascites, and pericardial effusion) after pumping treatment,
aggravated chronic obstructive pulmonary disease, active pulmonary infection and/or
acute bacterial or fungal respiratory disease requiring intravenous antibiotic
treatment within 28 days
- Have an obvious factor influencing oral drug absorption, such as unable to swallow,
chronic diarrhea and intestinal obstruction, etc
- Have venous thromboembolism events within 6 months before enrollment, such as
cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage,
cerebral infarction), deep vein thrombosis and pulmonary embolism, etc
- Have received live or attenuated vaccine within 30 days prior to the initial
administration of Penpulimab, or was scheduled to receive live or attenuated vaccine
during the study
- Patients who have known a history of severe hypersensitivity to other monoclonal
antibodies
- Patients who have known a history of psychotropic substance abuse, alcohol abuse, or
drug abuse
- Uncontrolled active hepatitis after treatment (hepatitis b: HBsAg positive and HBV DNA
more than 1 x 104 copy /ml; Hepatitis c: HCV RNA is positive and liver function is
abnormal); Combined with hepatitis b and hepatitis c infection
- Serious diseases that endanger patients' safety or affect patients' completion of
research, according to the researchers' judgment
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