A Study Comparing the Efficacy and Safety Between IBI308 and Docetaxel in Patients With Advanced or Metastatic NSCLC

• Sponsor: Innovent Biologics (Suzhou) Co. Ltd. (Industry)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT03150875
• Collaborator: (none)
• Enrollment: 290
• Locations: 2
• Arms: 2
• Anticipated Duration (Months): 52
• Patients Per Site: 145
• Patients Per Site Per Month: 2.8

Study Details

Study Description

Brief Summary

Similar clinical trial results demonstrated that anti-PD-1 antibodies prolonged OS to approximately 9 months compared with 6 months in docetaxel group. Anti-PD-1 therapy in Chinese squamous NSCLC patients will be investigated in this clinical trial.

Additionally the correlation between PD-L1 expression and the response to IBI308 treatment in Chinese squamous cell NSCLC as well as the role of irRECIST in immune checkpoint inhibitor treatment evaluation will also be assessed

Condition or Disease	Intervention/Treatment	Phase
Non-small Cell Lung Cancer	Drug: IBI308; Drug: Docetaxel	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 290 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Efficacy and Safety Evaluation of IBI308 Versus Docetaxel in Patients With Advanced or Metastatic Squamous Cell Lung Cancer After Failure of First-line Platinum-based Therapy- a Randomized, Open-label, Multicenter, Parallel, Phase 3 Study (ORIENT-3)
• Actual Study Start Date: Sep 1, 2017
• Actual Primary Completion Date: Jul 31, 2020
• Anticipated Study Completion Date: Dec 31, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: IBI308 injection; dosage form: 10ml:100mg; frequency: 200mgQ3W; duration: randomization to the date of the first documented tumor progression per RECIST v1.1 criteria	Drug: IBI308; Anti-PD-1 therapy in Chinese squamous NSCLC patients will be investigated in this clinical trial.
Active Comparator: docetaxel injection; dosage form: 1ml:40mg; Frequency: 75mg/m2 Q3W; duration: randomization to the date of the first documented tumor progression per RECIST v1.1 criteria	Drug: Docetaxel; As 2nd line treatment to subjects with squamous NSCLC

Outcome Measures

Primary Outcome Measures

1. Overall Survival [Through database cutoff date of 31-July-2020 (up to approximately 35 months)]

   Overall survival was defined as the time from randomization to death due to any cause.

Secondary Outcome Measures

1. Progression-free Survival by Investigators' Assessment [Through database cutoff date of 31-July-2020 (up to approximately 35 months)]

   Progression-free survival (PFS) was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first. Per Response Evaluation Criteria in Solid Tumours (RECIST 1.1), PD was defined as ≥20% increase in the sum of diameters of target lesions, or unequivocal progression of non-target lesion. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. PFS as assessed by investigators per RECIST 1.1 was reported for each arm.

2. Overall Response Rate (ORR) Per RECIST v1.1 as Assessed by Investigators [Through database cutoff date of 31-July-2020 (up to approximately 35 months)]

   ORR was defined as the percentage of participants in the analysis population who had a confirmed Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters) per RECIST 1.1. The percentage of participants who experienced a CR or PR is presented.

3. Duration of Response (DOR) Per RECIST v1.1 as Assessed by Investigators [Through database cutoff date of 31-July-2020 (up to approximately 35 months)]

   For participants who demonstrated a CR (disappearance of all target lesions) or PR (≥30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR was defined as the time from first documented evidence of a CR or PR until PD or death. DOR for participants who had not progressed or died at the time of analysis was to be censored at the date of their last tumor assessment. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions or unequivoval progression of non-target lesion. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. Note: The appearance of one or more new lesions was also considered PD. The DOR per RECIST 1.1 for all participants who experienced a CR or PR is presented.

4. Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAE) [Through database cutoff date of 31-July-2020 (up to approximately 35 months)]

   TEAE is any AE that developed or worsened in severity compared to the baseline during the period from first dose of any study treatment up to 90 days after the last dose of any study treatment. Percentage of participants experiencing TEAE is calculated.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Subjects with Histologically or cytologically confirmed squamous cell NSCLC

2. Subjects with stage IIIB/stage IV or recurrent disease (not suitable for definitive concurrent chemoradiotherapy) (according to version 7 of the International Association for the Study of Lung Cancer Staging Manual in Thoracic Oncology) after failure of first-line platinum-based therapy; Subjects who developed recurrent disease <6 months after platinum-containing adjuvant, neoadjuvant or definitive chemoradiation therapy also could also be eligible.

3. At lease one measurable disease according to Response Evaluation Criteria In Solid Tumors (RECIST) 1.1

4. Age ≥ 18 and ≤ 75

5. ECOG performance status 0-1

6. Life expectancy of at least 12 weeks

7. Adequate organ and bone marrow function

8. CBC: absolute neutrophil count (ANC) ≥ 1.5 × 109 / L; platelet count (PLT) ≥ 100 × 109 / L; hemoglobin content (HGB) ≥ 9.0 g / dL.

9. Liver function: serum total bilirubin (TBIL) ≤ 1.5 × normal upper limit (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN; serum albumin ≥ 28 g / L.

10. Renal function: serum creatinine (Cr) ≤ 1.5 × ULN, or creatinine clearance rate (Ccr) ≥ 40 mL / min (calculated using Cockcroft / Gault equation) Female:CrCl= (140-Age) x Weight(kg) x 0.85 72 x Serum creatinine (mg/dL) Male:CrCl= (140-Age) x Weight(kg) x 1.00 72 x Serum creatinine (mg/dL)

11. Subjects of reproductive potential must be willing to use adequate contraception during the course of the study and through 6 months after the last dose of study treatment.

12. Voluntarily signed written informed consent form, willing and able to comply with scheduled visits and other requirements of the study

Exclusion Criteria:

1. EGFR mutation and ALK rearrangement

2. Mixed adeno-squamous carcinoma or other pathological type

3. Prior therapy with anti-PD-1,anti-PD-L1,anti-CTLA4 antibody or docetaxel

4. Have received following treatment:

5. Received any investigational agent within 4 weeks of the first dose of study treatment.

6. Received any anti-tumor therapy (chemotherapy, targeted therapy, tumor immunotherapy or arterial embolization) within 3 weeks of the first dose of study treatment.

7. Received radiotherapy within 4 weeks of the first dose of study treatment.

8. Received systemic treatment with high-dose corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive drugs within 4 weeks of first dose. Inhaled or topical steroids and adrenal replacement steroid are permitted in the absence of active autoimmune disease.

9. Received attenuated live vaccine within 4 weeks of the first dose of study medication or plan to receive live vaccine during study period.

10. Received major surgery (such as craniotomy, thoracotomy or laparotomy) within 4 weeks of the first dose of study drugs or open wound, ulcer or fracture.

11. Unrecovered toxicity (grade >1, according to NCI CTCAE 4.03) due to prior anti-tumor therapy before the first dose of study treatment.

12. Subjects with active, known or suspected autoimmune disease such as interstitial pneumonia, uveitis, Crohn's disease, autoimmune thyroiditis. Subjects with cured childhood asthma, type I diabetes mellitus and hypothyroidism only requiring hormone replacement, or skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment.

13. Known history of allogeneic organ or allogeneic hemopoietic stem cell transplantation

14. Known allergic or hypersensitive to docetaxel, any monoclonal antibody or any other components used in their preparation.

15. Hemoptysis within 4 weeks of randomization (≥ 1/2 spoon per time).

16. Received thoracic radiotherapy >30Gy within 6 months or palliative radiotherapy (brain or bone metastasis) ≤30Gy within 7 days of randomization.

17. Symptomatic central nervous system (CNS) metastasis and/or carcinomatous meningitis. Subjects should have stable disease more than 4 weeks from first dose of study treatment, with neurological symptoms returned to NCI CTCAE 4.03 grade 0 or 1, are permitted to enroll.

18. Subjects with a history of interstitial lung disease

19. Superior vena caval obstruction syndrome;

20. Uncontrolled third space effusion, eg. ascites or pleural effusion.

21. Uncontrolled concomitant disease, including but not limited to :

22. Active or poorly controlled severe infection

23. Human Immunodeficiency Virus (HIV) infection (HIV antibody positive)

24. Known acute or chronic active hepatitis B (HBV DNA positive) infection or acute or chronic active hepatitis C (HCV antibody positive and HCV RNA positive) infection

25. Active tuberculosis

26. Symptomatic congestive heart failure (New York Heart Association grade III-IV) or symptomatic, poorly controlled arrhythmia

27. Uncontrolled hypertension (SBP ≥ 160mmHg or DBP ≥ 100mmHg)

28. Prior arterial thromboembolism event, including myocardial infarction, unstable angina, stroke and transient ischemic attack, within 6 months of enrollment

29. Concomitant disease needs anticoagulant therapy

30. Uncontrolled hypercalcemia(Ca2+>1.5mmol/L or Ca >12mg/dl or corrected Serum Calcium >ULN),or Symptomatic hypercalcemia during diphosphonate therapy

31. Other primary malignancy, with the exception of: (radical Non-melanoma skin cancer or cured cervical in-situ carcinoma;)

32. Subjects with other diseases or abnormal Lab test results which might increase the risk of enrollment and treatment or Interfere with the interpretation of study results could be excluded according to the judgments of investigator.

33. Women who are pregnant or nursing

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The First Affiliated Hospital Zhejiang University	Hangzhou	Zhejiang	China
2	Jiangsu Cancer Hospital	Nanjing		China

Sponsors and Collaborators

• Innovent Biologics (Suzhou) Co. Ltd.

Investigators

• Principal Investigator: Yuankai Shi, Doctor, Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jan 14, 2020

More Information

Publications

None provided.

• Responsible Party: Innovent Biologics (Suzhou) Co. Ltd.
• ClinicalTrials.gov Identifier: NCT03150875
• Other Study ID Numbers: CIBI308C301
• First Posted: May 12, 2017
• Last Update Posted: Jun 23, 2021
• Last Verified: May 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Lung Neoplasms; Docetaxel

Study Results

Participant Flow

Recruitment Details	Final analysis data cutoff date: 31-July-2020. Of the 290 randomized participants, 14 were ongoing. For efficacy analysis, full analysis set (FAS), Sintilimab (145) and Docetaxel (135), was used. 10 participants in the docetaxel arm who initiated immunotherapy before receving docetaxcel or disease progression were excluded from FAS.

Arm/Group Title	Sintilimab	Docetaxel
Arm/Group Description	Sintilimab 200mg Intravenously every 3 weeks	Docetaxel 75mg/m2 Intravenously every 3 weeks
Period Title: Overall Study
STARTED	145	145
Treated	144	130
Crossover to Certain Treatment	0	0
COMPLETED	0	0
NOT COMPLETED	145	145

Baseline Characteristics

Arm/Group Title	Sintilimab	Docetaxel	Total
Arm/Group Description	Sintilimab 200mg Intravenously every 3 weeks	Docetaxel 75mg/m2 Intravenously every 3 weeks	Total of all reporting groups
Overall Participants	145	135	280
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	60.6 (8.19)	59.5 (8.41)	60.1 (8.30)
Sex: Female, Male (Count of Participants)
Female	9 6.2%	13 9.6%	22 7.9%
Male	136 93.8%	122 90.4%	258 92.1%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%	0 0%	0 0%
Not Hispanic or Latino	145 100%	135 100%	280 100%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	145 100%	135 100%	280 100%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	0 0%	0 0%	0 0%
White	0 0%	0 0%	0 0%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
China	145 100%	135 100%	280 100%

Outcome Measures

1. Primary Outcome

Title	Overall Survival
Description	Overall survival was defined as the time from randomization to death due to any cause.
Time Frame	Through database cutoff date of 31-July-2020 (up to approximately 35 months)

Outcome Measure Data

Analysis Population Description

All randomized participants excluding participants in the docetaxel arm who initiated immunotherapy before receiving docetaxel or disease progression.

Arm/Group Title	Sintilimab	Docetaxel
Arm/Group Description	Sintilimab 200mg Intravenously every 3 weeks	Docetaxel 75mg/m2 Intravenously every 3 weeks
Measure Participants	145	135
Median (95% Confidence Interval) [Months]	11.79	8.25

2. Secondary Outcome

Title	Progression-free Survival by Investigators' Assessment
Description	Progression-free survival (PFS) was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first. Per Response Evaluation Criteria in Solid Tumours (RECIST 1.1), PD was defined as ≥20% increase in the sum of diameters of target lesions, or unequivocal progression of non-target lesion. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. PFS as assessed by investigators per RECIST 1.1 was reported for each arm.
Time Frame	Through database cutoff date of 31-July-2020 (up to approximately 35 months)

Outcome Measure Data

Analysis Population Description

All randomized participants excluding participants in the docetaxel arm who initiated immunotherapy before receiving docetaxel or disease progression.

Arm/Group Title	Sintilimab	Docetaxel
Arm/Group Description	Sintilimab 200mg Intravenously every 3 weeks	Docetaxel 75mg/m2 Intravenously every 3 weeks
Measure Participants	145	135
Median (95% Confidence Interval) [Months]	4.3	2.79

3. Secondary Outcome

Title	Overall Response Rate (ORR) Per RECIST v1.1 as Assessed by Investigators
Description	ORR was defined as the percentage of participants in the analysis population who had a confirmed Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters) per RECIST 1.1. The percentage of participants who experienced a CR or PR is presented.
Time Frame	Through database cutoff date of 31-July-2020 (up to approximately 35 months)

Outcome Measure Data

Analysis Population Description

All randomized participants excluding participants in the docetaxel arm who initiated immunotherapy before receiving docetaxel or disease progression.

Arm/Group Title	Sintilimab	Docetaxel
Arm/Group Description	Sintilimab 200mg Intravenously every 3 weeks	Docetaxel 75mg/m2 Intravenously every 3 weeks
Measure Participants	145	135
Number (95% Confidence Interval) [Percentage of participants]	25.5 17.6%	2.2 1.6%

4. Secondary Outcome

Title	Duration of Response (DOR) Per RECIST v1.1 as Assessed by Investigators
Description	For participants who demonstrated a CR (disappearance of all target lesions) or PR (≥30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR was defined as the time from first documented evidence of a CR or PR until PD or death. DOR for participants who had not progressed or died at the time of analysis was to be censored at the date of their last tumor assessment. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions or unequivoval progression of non-target lesion. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. Note: The appearance of one or more new lesions was also considered PD. The DOR per RECIST 1.1 for all participants who experienced a CR or PR is presented.
Time Frame	Through database cutoff date of 31-July-2020 (up to approximately 35 months)

Outcome Measure Data

Analysis Population Description

All responders

Arm/Group Title	Sintilimab	Docetaxel
Arm/Group Description	Sintilimab 200mg Intravenously every 3 weeks	Docetaxel 75mg/m2 Intravenously every 3 weeks
Measure Participants	40	7
Median (95% Confidence Interval) [Months]	12.45	4.14

5. Secondary Outcome

Title	Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAE)
Description	TEAE is any AE that developed or worsened in severity compared to the baseline during the period from first dose of any study treatment up to 90 days after the last dose of any study treatment. Percentage of participants experiencing TEAE is calculated.
Time Frame	Through database cutoff date of 31-July-2020 (up to approximately 35 months)

Outcome Measure Data

Analysis Population Description

All participants who received ≥1 dose of study treatment

Arm/Group Title	Sintilimab	Docetaxel
Arm/Group Description	Sintilimab 200mg Intravenously every 3 weeks	Docetaxel 75mg/m2 Intravenously every 3 weeks
Measure Participants	144	130
Number [Percentage of participants]	97.20 67%	96.20 71.3%

Adverse Events

Time Frame	Through database cutoff date of 31-July-2020 (up to approximately 35 months)
Adverse Event Reporting Description	All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Arm/Group Title	Sintilimab		Docetaxel
Arm/Group Description	Sintilimab 200mg Intravenously every 3 weeks		Docetaxel 75mg/m2 Intravenously every 3 weeks
All Cause Mortality
	Sintilimab		Docetaxel
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	108/144 (75%)		101/130 (77.7%)
Serious Adverse Events
	Sintilimab		Docetaxel
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	56/144 (38.9%)		34/130 (26.2%)
Blood and lymphatic system disorders
Bone marrow failure	0/144 (0%)		1/130 (0.8%)
Febrile neutropenia	0/144 (0%)		1/130 (0.8%)
Cardiac disorders
Cardiac failure	1/144 (0.7%)		0/130 (0%)
Cardiomyopathy	1/144 (0.7%)		0/130 (0%)
Myocardial infarction	1/144 (0.7%)		0/130 (0%)
Myocarditis	1/144 (0.7%)		0/130 (0%)
Sinus bradycardia	1/144 (0.7%)		0/130 (0%)
Sinus tachycardia	0/144 (0%)		1/130 (0.8%)
Endocrine disorders
Hyperthyroidism	1/144 (0.7%)		0/130 (0%)
Gastrointestinal disorders
Abdominal discomfort	0/144 (0%)		1/130 (0.8%)
Diarrhoea	1/144 (0.7%)		0/130 (0%)
Dysphagia	1/144 (0.7%)		0/130 (0%)
Gastric varices haemorrhage	0/144 (0%)		1/130 (0.8%)
Gastritis	1/144 (0.7%)		0/130 (0%)
Nausea	1/144 (0.7%)		0/130 (0%)
Vomiting	2/144 (1.4%)		0/130 (0%)
General disorders
Asthenia	2/144 (1.4%)		2/130 (1.5%)
Chest discomfort	1/144 (0.7%)		0/130 (0%)
Death	2/144 (1.4%)		0/130 (0%)
Fatigue	1/144 (0.7%)		0/130 (0%)
Pain	0/144 (0%)		1/130 (0.8%)
Pyrexia	5/144 (3.5%)		3/130 (2.3%)
Hepatobiliary disorders
Cholecystitis acute	0/144 (0%)		1/130 (0.8%)
Drug-induced liver injury	1/144 (0.7%)		0/130 (0%)
Infections and infestations
Anal abscess	1/144 (0.7%)		2/130 (1.5%)
Bronchitis	0/144 (0%)		1/130 (0.8%)
Encephalitis	1/144 (0.7%)		0/130 (0%)
Influenza	2/144 (1.4%)		0/130 (0%)
Myelitis	1/144 (0.7%)		0/130 (0%)
Pneumonia	12/144 (8.3%)		14/130 (10.8%)
Pneumonia fungal	1/144 (0.7%)		0/130 (0%)
Sepsis	1/144 (0.7%)		0/130 (0%)
Upper respiratory tract infection	2/144 (1.4%)		2/130 (1.5%)
Urinary tract infection	1/144 (0.7%)		0/130 (0%)
Injury, poisoning and procedural complications
Humerus fracture	1/144 (0.7%)		0/130 (0%)
Infusion related reaction	1/144 (0.7%)		0/130 (0%)
Urethral injury	1/144 (0.7%)		0/130 (0%)
Investigations
Alanine aminotransferase increased	2/144 (1.4%)		0/130 (0%)
Aspartate aminotransferase increased	2/144 (1.4%)		0/130 (0%)
Blood bilirubin increased	1/144 (0.7%)		0/130 (0%)
Gamma-glutamyltransferase increased	1/144 (0.7%)		0/130 (0%)
Neutrophil count decreased	0/144 (0%)		4/130 (3.1%)
Platelet count increased	0/144 (0%)		1/130 (0.8%)
Transaminases increased	1/144 (0.7%)		0/130 (0%)
White blood cell count decreased	0/144 (0%)		5/130 (3.8%)
Metabolism and nutrition disorders
Decreased appetite	0/144 (0%)		1/130 (0.8%)
Hypercalcaemia	0/144 (0%)		1/130 (0.8%)
Type 2 diabetes mellitus	1/144 (0.7%)		0/130 (0%)
Musculoskeletal and connective tissue disorders
Myalgia	0/144 (0%)		1/130 (0.8%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain	1/144 (0.7%)		0/130 (0%)
Colon adenoma	1/144 (0.7%)		0/130 (0%)
Gastric cancer	1/144 (0.7%)		0/130 (0%)
Pituitary tumour	0/144 (0%)		1/130 (0.8%)
Nervous system disorders
Lacunar infarction	1/144 (0.7%)		0/130 (0%)
Myasthenia gravis	1/144 (0.7%)		0/130 (0%)
Renal and urinary disorders
Acute kidney injury	1/144 (0.7%)		0/130 (0%)
Nephrolithiasis	1/144 (0.7%)		0/130 (0%)
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease	2/144 (1.4%)		0/130 (0%)
Dyspnoea	1/144 (0.7%)		2/130 (1.5%)
Haemoptysis	4/144 (2.8%)		2/130 (1.5%)
Immune-mediated pneumonitis	3/144 (2.1%)		0/130 (0%)
Interstitial lung disease	4/144 (2.8%)		0/130 (0%)
Pneumonitis	3/144 (2.1%)		0/130 (0%)
Pneumothorax	1/144 (0.7%)		1/130 (0.8%)
Pulmonary embolism	0/144 (0%)		2/130 (1.5%)
Respiratory failure	3/144 (2.1%)		0/130 (0%)
Vascular disorders
Shock	1/144 (0.7%)		0/130 (0%)
Venous thrombosis limb	0/144 (0%)		1/130 (0.8%)
Other (Not Including Serious) Adverse Events
	Sintilimab		Docetaxel
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	132/144 (91.7%)		117/130 (90%)
Blood and lymphatic system disorders
Anaemia	48/144 (33.3%)		43/130 (33.1%)
Cardiac disorders
Sinus tachycardia	12/144 (8.3%)		7/130 (5.4%)
Endocrine disorders
Hyperthyroidism	11/144 (7.6%)		0/130 (0%)
Hypothyroidism	27/144 (18.8%)		2/130 (1.5%)
Gastrointestinal disorders
Constipation	23/144 (16%)		14/130 (10.8%)
Diarrhoea	12/144 (8.3%)		13/130 (10%)
Nausea	16/144 (11.1%)		12/130 (9.2%)
Vomiting	11/144 (7.6%)		6/130 (4.6%)
General disorders
Asthenia	25/144 (17.4%)		33/130 (25.4%)
Chest pain	8/144 (5.6%)		8/130 (6.2%)
Pain	9/144 (6.3%)		3/130 (2.3%)
Pyrexia	31/144 (21.5%)		21/130 (16.2%)
Infections and infestations
Nasopharyngitis	9/144 (6.3%)		1/130 (0.8%)
Pneumonia	11/144 (7.6%)		11/130 (8.5%)
Upper respiratory tract infection	17/144 (11.8%)		7/130 (5.4%)
Urinary tract infection	11/144 (7.6%)		4/130 (3.1%)
Investigations
Alanine aminotransferase increased	25/144 (17.4%)		6/130 (4.6%)
Aspartate aminotransferase increased	23/144 (16%)		7/130 (5.4%)
Blood bilirubin increased	9/144 (6.3%)		1/130 (0.8%)
Blood urine present	8/144 (5.6%)		1/130 (0.8%)
Gamma-glutamyltransferase increased	14/144 (9.7%)		5/130 (3.8%)
Haemoglobin decreased	3/144 (2.1%)		9/130 (6.9%)
Lymphocyte count decreased	8/144 (5.6%)		9/130 (6.9%)
Neutrophil count decreased	7/144 (4.9%)		38/130 (29.2%)
Platelet count decreased	6/144 (4.2%)		8/130 (6.2%)
Weight decreased	29/144 (20.1%)		14/130 (10.8%)
Weight increased	10/144 (6.9%)		7/130 (5.4%)
White blood cell count decreased	6/144 (4.2%)		39/130 (30%)
Metabolism and nutrition disorders
Decreased appetite	34/144 (23.6%)		23/130 (17.7%)
Hyperglycaemia	15/144 (10.4%)		6/130 (4.6%)
Hyperuricaemia	9/144 (6.3%)		2/130 (1.5%)
Hypoalbuminaemia	18/144 (12.5%)		13/130 (10%)
Hypochloraemia	13/144 (9%)		3/130 (2.3%)
Hypokalaemia	14/144 (9.7%)		7/130 (5.4%)
Hyponatraemia	25/144 (17.4%)		5/130 (3.8%)
Musculoskeletal and connective tissue disorders
Arthralgia	8/144 (5.6%)		4/130 (3.1%)
Back pain	6/144 (4.2%)		10/130 (7.7%)
Musculoskeletal pain	6/144 (4.2%)		7/130 (5.4%)
Pain in extremity	10/144 (6.9%)		6/130 (4.6%)
Nervous system disorders
Dizziness	8/144 (5.6%)		3/130 (2.3%)
Headache	5/144 (3.5%)		7/130 (5.4%)
Renal and urinary disorders
Proteinuria	21/144 (14.6%)		4/130 (3.1%)
Respiratory, thoracic and mediastinal disorders
Cough	29/144 (20.1%)		19/130 (14.6%)
Dyspnoea	11/144 (7.6%)		7/130 (5.4%)
Haemoptysis	19/144 (13.2%)		9/130 (6.9%)
Skin and subcutaneous tissue disorders
Alopecia	0/144 (0%)		45/130 (34.6%)
Pruritus	10/144 (6.9%)		0/130 (0%)
Rash	24/144 (16.7%)		5/130 (3.8%)
Vascular disorders
Hypertension	12/144 (8.3%)		2/130 (1.5%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.