. 2020 Oct 7;11:73–103. doi: 10.2147/LCTT.S258444

Table 7.

Ongoing and Future Clinical Trials for Epidermal Growth Factor Receptor Mutated Non-Small Cell Lung Cancer

Protocol Name	Phase	Patient Population	Treatment Regimen	Target Sample Size (n)	Primary Outcomes	Secondary Outcomes
NCT04035486 (FLAURA2)⁹⁰	III	Treatment naïve EGFR mutated locally advanced or metastatic NSCLC	Osimertinib + pemetrexed + cisplatin or carboplatin	586	PFS	OS, ORR, DOR, DCR
NCT04099836 (TOP 1901)⁹¹	II	EGFR mutated NSCLC in patients with progressive disease on osimertinib	Atezolizumab + bevacizumab	39	ORR	PFS, OS, safety
NCT04206787 ⁹²	III	EGFR mutated advanced NSCLC receiving afatinib as first line treatment	Sequential afatinib treatments (observatory)	825	TOT	OS, PFS, ORR, DCR
NCT04335292 (OCELOT)⁹³	II	Previously treated with osimertinib and second line platinum and pemetrexed	Osimertinib	200	ORR	PFS, DOR, DCR, OS, TTF, QOL
NCT04239833 ⁹⁴	III	Treatment naïve EGFR mutated locally advanced or metastatic NSCLC	SH-1028	240	PFS	ORR, DOR, DCR, OS, safety
NCT03255083 ⁹⁵	I	EGFR mutated locally advanced or metastatic NSCLC who have progressed on an EGFR TKI	DS-1205c + osimertinib	13	Safety	PD, PK, ORR, DCR, PFS, OS
NCT03940703 ⁹⁶	II	MET Amplified, EGFR mutated advanced or metastatic NSCLC having acquired resistance to prior EGFR TKI	Tepotinib + osimertinib	90	Safety, ORR	DOR, DCR, PFS, OS, QOL
NCT03599518 ⁹⁷	I	EGFR mutated metastatic or unresectable NSCLC having acquired resistance to EGFR TKI	DS-1205c + gefitinib	63	Safety	PD, PK, ORR, DOR, DCR, PFS, OS
NCT03446417 ⁹⁸	I/II	EGFR mutated advanced NSCLC who have progressed on EGFR TKI	ZN-e4	140	Safety	Safety
NCT04351555 (NeoADAURA)⁹⁹	III	EGFR mutated resectable NSCLC	Osimertinib + pemetrexed + cisplatin or carboplatin	351	MPR	PCR, EFS, OS, DFS, QOL
NCT01532089 ¹⁰⁰	II	Treatment naïve EGFR mutated metastatic NSCLC	Erlotinib + bevacizumab	88	PFS	OS, ORR, safety
NCT03909334 ¹⁰¹	II	Treatment naïve EGFR mutated locally advanced or metastatic NSCLC	Osimertinib + ramucirumab	150	PFS	ORR, DCR, OS, safety
NCT03382795 ¹⁰²	II	EGFR mutated advanced NSCC NSCLC who have progressed on EGFR TKI and chemotherapy	Gefitinib or erlotinib	69	ORR	PFS, OS, safety
NCT02864251 (CheckMate722)¹⁰³	III	EGFR mutated advanced NSCLC who have progressed first or second line EGFR TKI	Nivolumab + chemotherapy or nivolumab + ipilimumab	580	PFS	OS, ORR, DOR
NCT02347839 (NEGOTIATE)¹⁰⁴	II	EGFR mutated stage III unresectable NSCLC	Neoadjuvant gefitinib followed by surgery + gefitinib	37	Resectability rate	Perioperative complications, EFS, OS
NCT01996098 (ICTAN)¹⁰⁵	III	EGFR mutated stage IIA-IIIA unresectable NSCLC	Icotinib following chemotherapy	318	DFS	OS, safety, QOL
NCT04141644 ¹⁰⁶	IB	EGFR mutated locally advanced or metastatic NSCLC stable on osimertinib	Osimertinib + ipilimumab	26	Safety	ORR, PFS, OS
NCT04085315 ¹⁰⁷	I	EGFR mutated metastatic NSCLC who have progressed on or stable on osimertinib	Alisertib + osimertinib	36	Safety	ORR, DOR, DCR, PFS, OS, CNS DCR
NCT04248829 (LASER301)¹⁰⁸	III	Treatment naïve EGFR mutated locally advanced or metastatic NSCLC	Lazertinib	380	PFS	ORR, DOR, DCR, OS, QOL, CNS responses
NCT03532698 ¹⁰⁹	III	EGFR T790M mutated metastatic NSCLC who have progressed on osimertinib	Osimertinib + aspirin	100	ORR	DCR, TTP, DOR
NCT03861156 ¹¹⁰	II	EGFR mutated locally advanced or metastatic NSCLC who have progressed on EGFR TKI and have a T790M mutation	D-0316	286	ORR	PFS, OS, DOR, DCR, CNS response
NCT03126799 ¹¹¹	II	Treatment naïve EGFR mutated advanced or metastatic NSCLC	Erlotinib + bevacizumab	128	PFS	ORR, OS
NCT03904823 ¹¹²	II	Treatment naïve EGFR mutated locally advanced or metastatic NSCLC	Famitinib + HS-10,296	58	ORR	DOR, DCR, PFS, safety
NCT02973763 ¹¹³	I	EGFR mutated advanced NSCLC who have progressed on an EGFR TKI and have a T790M mutation	Alflutinib	14	Safety	PK, PD, ORR, DOR, PFS
NCT03802240 (ORIENT-31)¹¹⁴	III	EGFR mutated locally advanced or metastatic non-squamous NSCLC who have progressed on EGFR-TKI	Sintilimab ± IBI305 + pemetrexed + cisplatin	600	PFS	OS, ORR
NCT03502850 ¹¹⁵	I/II	EGFR mutated locally advanced or metastatic NSCLC who have progressed on EGFR-TKI	ASK120067	135	ORR	Safety, PFS, DOR, DCR, OS, PK, PD
NCT03807778 ¹¹⁶	I/II	EGFR mutated, exon 20 locally advanced or metastatic NSCLC who have progressed on EGFR-TKI	TAK-788	63	Safety	PK, PD, ORR, DOR, DCR, PFS, OS, QOL
NCT03799094 ¹¹⁷	III	EGFR mutated locally advanced or metastatic NSCLC	Vitamin C + EGFR TKI	150	PFS	OS, QOL
NCT03769103 ¹¹⁸	II	Treatment naïve EGFR mutated metastatic NSCLC with BM	Osimertinib + SRS	76	CNS PFS	CNS OS, time to SRS/WBRT, OS, QOL
NCT04153799 ¹¹⁹	I	EGFR mutated locally advanced or metastatic NSCLC	CXCR5 Modified EGFR CAR-T	11	Safety, ORR	PK, PD, DOR, PFS
NCT03201146 ¹²⁰	I/II	Treatment naïve EGFR mutated locally advanced or metastatic NSCLC	Apatinib + pemetrexed + cisplatin or carboplatin	48	ORR	PFS, DCR, OS
NCT02954523 ¹²¹	I/II	Treatment naïve EGFR mutated locally advanced or metastatic NSCLC	Osimertinib + dasatinib	10	Safety	PK, PD, PFS, OS, DOR
NCT03727724 (AFACET)¹²²	II	EGFR mutated, exon 20 locally advanced or metastatic NSCLC	Afatinib + cetuximab	37	DCR	ORR, safety, DOR, PFS, OS
NCT02716311 (ACE-Lung)¹²³	II	Treatment naïve EGFR mutated locally advanced or metastatic NSCLC	Afatinib + cetuximab	118	TTF	Safety, ORR, OS, PFS
NCT01897480 (Balise)¹²⁴	II	Treatment naïve EGFR mutated locally advanced or metastatic NSCLC who have disease control after an 8-week lead-in with erlotinib	LY2875358 + erlotinib	150	PFS	ORR, DOR, OS, PK
NCT02503722 ¹²⁵	I	EGFR mutated advanced or metastatic NSCLC who have progressed on osimertinib	Sapanisertib + osimertinib	36	Safety	PK, PD, ORR, DCR, PFS
NCT03521154 (LAURA)¹²⁶	III	EGFR mutated stage III unresectable NSCLC	Osimertinib following chemoradiation	200	PFS	CNS PFS, OS, ORR, DOR, DCR, safety
NCT02789345 ¹²⁷	I	EGFR mutated advanced NSCLC who have progressed on an EGFR TKI and have a T790M mutation	Osimertinib + ramucirumab or necitumumab	74	Safety	PK, PD, ORR, DCR, DOR, PFS, OS
NCT04129502 ¹²⁸	III	Treatment naïve EGFR mutated, exon 20 locally advanced or metastatic NSCLC	TAK-788	318	PFS	ORR, OS, DOR, DCR, QOL
NCT03811054 ¹²9	II	EGFR mutated advanced or metastatic NSCLC with slow progression on an EGFR TKI	Apatinib + EGFR-TKI	60	ORR	DCR, OS, PFS, safety
NCT03434418 ¹³⁰	II	Treatment naïve uncommon EGFR mutated locally advanced or metastatic NSCLC (exon 18 G719X, exon 20 S768I, or exon 21 L861Q)	Osimertinib	37	ORR	PFS, safety, OS
NCT04036682 ¹³¹	I/IIA	EGFR mutated, exon 20 locally advanced or metastatic NSCLC previously treated with platinum based chemotherapy	CLN-081	80	Safety	ORR, DOR, DCR, PFS, OS, PK, PD
NCT04426825 ¹³²	II	EGFR mutated advanced or metastatic NSCLC previously treated with an EGFR TKI	Atezolizumab + bevacizumab	60	PFS	ORR, DOR, OS, safety
NCT02820116 ¹³3	II	EGFR mutated stage IIIA - IIIB NSCLC	Neoadjuvant icotinib	67	CRR	ORR, DCR, PFS, OS, safety
NCT03091491 ¹³⁴	II	EGFR mutated advanced or metastatic NSCLC who have progressed on an EGFR TKI	Nivolumab + ipilimumab	184	ORR	PFS, DOR, OS, safety
NCT01982955 (INSIGHT)¹³⁵	IB/II	EGFR mutated advanced or metastatic MET positive NSCLC who have progressed on an EGFR TKI	Tepotinib + gefitinib	70	Safety	PFS, OS, ORR, DCR, PK, PD, QOL
NCT04148898 ¹³⁶	II	EGFR mutated advanced or metastatic NSCLC with leptomeningeal metastasis	Osimertinib + bevacizumab	80	CNS PFS, ORR	CNS OS, PFS, safety
NCT03603262 ¹³⁷	I	EGFR mutated advanced or metastatic NSCLC who have progressed on an EGFR TKI	SH-1028	85	Safety, PK, PD	ORR, PFS, DCR, OS
NCT02438722 ¹³⁸	II/III	Treatment naïve EGFR mutated locally advanced or metastatic NSCLC	Afatinib + cetuximab	174	PFS, OS	ORR, TTF, safety
NCT04206072 ¹³⁹	II/III	Treatment naïve EGFR mutated locally advanced or metastatic NSCLC	D-0316	360	PFS	ORR, DOR, DCR, OS, CNS PFS, safety
NCT01405079 ¹⁴⁰	III	EGFR mutated stage II–IIIA (N1-N2) NSCLC	Gefitinib	222	DFS	OS, safety, QOL
NCT02716116 ¹⁴¹	I/II	EGFR/HER2 mutated locally advanced or metastatic NSCLC (also includes exon 20)	TAK-788	306	ORR	PK, PD, DOR, DCR, PFS, OS
NCT03755102 ¹⁴²	I	EGFR mutated advanced or metastatic NSCLC who have progressed on osimertinib	Dacomitinib + osimertinib	24	ORR	PFS, OS
NCT03122717 ¹⁴³	I/II	Treatment naïve EGFR mutated locally advanced or metastatic NSCLC	Osimertinib + gefitinib	64	Safety	ORR, PFS, OS
NCT04425681 (OWBLM)¹⁴⁴	II	EGFR mutated advanced or metastatic NSCLC with leptomeningeal metastasis	Osimertinib + bevacizumab	20	CNS PFS, ORR	CNS OS, PFS, safety
NCT03396185 ¹⁴⁵	II	EGFR mutated stage IIIA-IIIB NSCLC	Icotinib following chemoradiation	30	RFS	OS, safety
NCT03428022 (AFLC)¹⁴⁶	III	EGFR mutated advanced or metastatic NSCLC with slow progression on an EGFR TKI	Apatinib + EGFR-TKI	54	PFS	OS, ORR
NCT04233021 (ORBITAL)¹⁴⁷	II	EGFR mutated advanced or metastatic NSCLC with brain or leptomeningeal metastasis	Osimertinib	113	ORR	OS, PFS, safety, QOL
NCT04143607 ¹⁴⁸	III	Treatment naïve EGFR mutated locally advanced or metastatic NSCLC	ASK120067	334	PFS	ORR, DOR, DCR, OS
NCT04405674 ¹⁴⁹	II	EGFR mutated advanced or metastatic NSCC NSCLC who have progressed on an EGFR TKI	Tislelizumab + carboplatin + nab-paclitaxel	66	PFS	ORR, DCR, OS, DOR
NCT03392246 ¹⁵⁰	II	Treatment naïve EGFR mutated locally advanced or metastatic NSCLC	Osimertinib + selumetinib	25	Best ORR	PFS, OS, safety
NCT01553942 (ASCENT Trial)¹⁵¹	II	Treatment naïve EGFR mutated stage III NSCLC	Afatinib + chemoradiation	30	ORR	PFS, safety, DCR
NCT03823807 ¹⁵²	II	EGFR mutated advanced NSCLC who have progressed on an EGFR TKI and have a T790M mutation	SH-1028	300	ORR	Safety, PK, PD, PFS, DOR, DCR, OS
NCT04204473 ¹⁵³	I	EGFR mutated advanced or metastatic NSCLC who have progressed on an EGFR TKI	TY-9591	126	Safety, ORR	PK, PD, PFS, DOR
NCT04358562 ¹⁵⁴	II	EGFR mutated advanced NSCC NSCLC with uncleared plasma ctDNA EGFR mutation after progression on gefitinib	Gefitinib + anlotinib	240	PFS	OS, ORR, safety
NCT02098954 ¹⁵⁵	II	EGFR mutated advanced or metastatic NSCLC who have progressed on an EGFR TKI	Erlotinib + gemcitabine + cisplatin	40	PFS	OS, ORR
NCT03066206 ¹⁵6	II	EGFR mutated, exon 20 locally advanced or metastatic NSCLC	Poziotinib	80	ORR	DCR, PFS, OS, DOR, safety
NCT01859026 ¹⁵⁷	I	EGFR or KRAS mutated advanced or metastatic NSCLC	MEK162 + erlotinib	43	Safety	PFS, OS
NCT02520778 ¹⁵⁸	I	EGFR mutated advanced or metastatic NSCLC who have progressed on an EGFR TKI	Osimertinib + navitoclax	50	Safety	PK, PD, ORR
NCT02824458 ¹⁵⁹	III	Treatment naïve EGFR mutated advanced or metastatic NSCC NSCLC	Gefitinib + apatinib	346	Safety, PFS	OS, ORR, DCR, DOR, QOL. PK, PD
NCT03653546 ¹⁶⁰	II/III	Treatment naïve EGFR mutated advanced or metastatic NSCLC with CNS metastases	AZD3759	432	PFS	CNS PFS, ORR, DCR, DOR, OS
NCT04007835 ¹⁶	II	EGFR mutated advanced or metastatic NSCLC who have progressed on an EGFR TKI	Anlotinib + EGFR TKI	120	PFS	ORR, DCR, OS, safety
NCT03831932 ¹⁶²	I/II	EGFR mutated advanced or metastatic NSCLC who have progressed on an EGFR TKI	CB-839 + osimertinib	53	Safety, ORR	PFS,OS, PK, PD
NCT00977470 ¹⁶³	II	Treatment naïve EGFR mutated advanced or metastatic NSCLC	Erlotinib + hydroxychloroquine	76	PFS	Safety, ORR, OS
NCT03341494 ¹⁶⁴	II	Treatment naïve EGFR mutated advanced or metastatic NSCLC	Gefitinib + thalidomide	128	PFS	ORR, OS
NCT02496663 ¹⁶⁵	I	EGFR mutated advanced or metastatic NSCLC who have progressed on an EGFR TKI	Osimertinib + necitumumab	100	Safety	ORR, PFS, DCR, PK, PD
NCT01746251 ¹⁶⁶	II	EGFR mutated Stage I–III NSCLC	Afatinib (adjuvant)	92	RFS	Safety, OS
NCT04181060 ¹⁶⁷	III	Treatment naïve EGFR mutated advanced or metastatic NSCLC	Osimertinib + bevacizumab	300	PFS	OS, ORR, time to CNS metastases, safety
NCT02917993 ¹⁶⁸	I/II	EGFR mutated advanced or metastatic NSCLC who have progressed on an EGFR TKI	Itacitinib + osimertinib	59	Safety, ORR	PK, PD, PFS, OS
NCT03983811 ¹⁶⁹	III	EGFR mutated Stage IIB-IIIA NSCLC	Icotinib + chemotherapy (adjuvant)	174	DFS	Safety
NCT03260491 ¹⁷⁰	I	EGFR mutated advanced or metastatic NSCLC who have progressed on an EGFR TKI	U3-1402	198	Safety, ORR	PK, PD, DCR, DOR, PFS, OS
NCT04042558 ¹⁷¹	II	Advanced or metastatic NSCLC who have progressed on a targeted therapy	Carboplatin + Pemetrexed + Atezolizumab + Bevacizumab	149	ORR	PFS, OS, DOR
NCT02609776 (CHRYSALIS)¹⁷²	I	EGFR mutated advanced or metastatic NSCLC who have progressed on an EGFR TKI	Lazertinib	460	Safety, ORR	PK, PD, PFS, OS
NCT03234712 ¹⁷³	I	Advanced solid tumors with overexpression EGFR	ABBV-321	120	PK, PD	PFS, DOR, DCR, OS, ORR
NCT01470716 ¹⁷⁴	II	EGFR mutated Stage II–IIIA NSCLC	Erlotinib (neoadjuvant)	26	PFS	ORR, OS, safety
NCT03778229 (SAVANNAH)¹⁷⁵	II	EGFR mutated advanced or metastatic NSCLC who have progressed on osimertinib	Osimertinib + savolitinib	192	ORR	PFS, QOL, OS, safety, DOR
NCT04201756 ¹⁷⁶	II	EGFR mutated Stage III resectable NSCLC	Afatinib (neoadjuvant)	47	ORR	DFS, OS, PFS, safety, QOL
NCT03623750 (EPICAL)¹⁷⁷	IB	Treatment naïve advanced or metastatic NSCLC	Afatinib + EGF-PTI + cyclophosphamide	30	Safety	Clinical outcomes

Abbreviations: BM, brain metastases; CAR-T, chimeric antigen receptor autologous T-Cells; CNS, central nervous system; CRR, complete resection rate; DCR, disease control rate; DFS, disease-free survival; DOR, duration of response; EGF-PTI, EGF pathway targeting immunization; EGFR, epidermal growth factor receptor; EFS, event-free survival; MET, mesenchymal-epithelial transition; MPR, major pathological response; NSCC, non-squamous cell carcinoma; NSCLC, non-small cell lung cancer; ORR, objective response rate; OS, overall survival; PCR, pathological complete response; PD, pharmacokinetics; PK, pharmacodynamics; PFS, progression-free survival; QOL, quality of life; SRS, stereotactic radiosurgery’ TKI, tyrosine kinase inhibitor; TOT, time on treatment; TTP, time to progression; TTF, time to treatment failure; WBRT, whole brain radiotherapy.